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Full text of "North Carolina Register v.13 no. 4 (8/14/1998)"

NORTH CAROLINA 

REGISTER 



VOLUMF 1 3 • ISSUE 4 • Pages 353 - 434 
August 14, 1998 



IN THIS ISSUE 

1 fe Resources 

I lent and Natural Resources 
Pharmacy. Board of 

■) 
I 
I 



I' I BI.ISHED BY 

The Office ofAdnn'nntro/lve Hearings 

Rules Division 

PO Drawer 27447 

Raleigh, NC 2761 1-7447 

Telephone (919) 733-2678 

Fax (919) 733-3462 



This publication is printed on permanent, acid-free paper in compliance with G.S. 125-11. 13 



For those persons that have questions or concerns regarding the Administrative Procedure Act or any of ijj 
components, consult with the agencies below. The bolded headings are typical issues which the gi' 
agency can address, but are not inclusive. 



1 



Rule Notices, Filings, Reeister. Deadlines, Copies of Proposed Rules, etc. 

Office of Administrative Hearings 

Rules Division • ] .- * 

Capehart-Crocker House ^ (919)733-2678 

424 North Blount Street (919) 733-3462 FAX 

Raleigh, North Carolina 27601-2817 



contact: Molly Masich, Director APA Services 
Ruby Creech, Publications Coordinator 



mmasich@oah.state.nc.us 
rcreechfSoah.state.nc.us 



Fiscal Notes & Economic Analysis 

Office of State Budget and Management 
116 West Jones Street 
/ Raleigh, North Carolina 27603-8005 

contact: Mark Sisak, Economist III 



(919)733-7061 
(919) 733-0640 FAX 

msisak@osbm.state.nc.us 



Rule Review and Legal Issues 

Rules Review Commission 
1307 Glenwood Ave., Suite 159 
Raleigh, North Carolina 27605 

contact: Joe DeLuca Jr., Staff Director Counsel 
Bobby Bryan. Staff Attorney 



(919)733-2721 
(919) 733-9415 FAX 



Legislative Process Concerning Rule-making 

Joint Legislative Administrative Procedure Oversight Committee 

545 Legislative Oflfice Building 

300 North Salisbury Street (9 1 9) 733-2578 

Raleigh, North Carolina 2761 1 (919) 715-5460 FAX 




n^a.state.nc.us 



contact: Mary Shuping, Staff Liaison 



County and Municipality Government Questions or Notification 

NC Association of County Commissioners 

215 North Dawson Street (919) 715-2893 

Raleigh, North Carolina 27603 

contact: Jim Blackburn or Rebecca Troutman 



« 



NC League of Municipalities 
2 1 5 North Dawson Street 
Raleigh, North Carolina 27603 

contact: Paula Thomas 



(919)715-4000 



1 



This publication is printed on permanent, acid-free paper in compliance with G.S. 125-11. 13 



NORTH CAROLINA 
REGISTER 



IN THIS ISSUE 




Volume 13, Issue 4 
Pages 353 - 434 



August 14, 1998 



This issue contains documents officially filed 
through July 24, 1998. 



I. IN ADDITION 

ENR - Wildlife Resources 353 

Voting Rights Letters 354-355 



II. RULE-MAKING AGENDA 

Environment and Natural Resources 

Environmental Management 356 - 359 

Health Services, Commission for 356 - 359 



m. RULE-MAKING PROCEEDINGS 
Administration 

Purchase and Contract Division 360 

State Building Commission 360 

State Employees Combined Campaign 360 - 361 

Environment and Natural Resources 
Coastal Resources Commission 361 

Transportation 
Highways, Division of 361 



IV. PROPOSED RULES 

Environment and Natural Resources 

ENR - Departmental Rules 362-368 

Environmental Management 368 - 378 

Radiation Protection Commission 378 - 419 

Licensing Boards 
Pharmacy, Board of 419-425 



Office of Administrative Hearings 

Rules Division 

424 North Blount Street (27601 ) 

PO Drawer 27447 

Raleigh, NC 2761 1-7447 

(919)733-2678 

FAX (919) 733-3462 



Julian Mann 111, Director 

Camille Winston, Deputy Director 

Molly Masich, Director of APA Services 

Ruby Creech, Publications Coordinator 

Jean Shirley, Editorial Assistant 

Linda Dupree, Editorial Assistant 



V. TEMPORARY RULES 

Environment and Natural Resources 

Environmental Management 426 - 427 

Wildlife Resources Commission 427 

VI. RULES REVIEW COMMISSION 428-430 

VII. CONTESTED CASE DECISIONS 

Index to ALJ Decisions 43 1 - 434 

VIII. CUMULATIVE INDEX 1-52 



\orih Carolina Register is published semi-monthly for $195 per year by the Office of Admmistrative Hearmgs. 424 North Blount Street. Raleigh. NC 
27601. (ISSN 15200604) to mail at Penodicals Rates is paid at Raleigh, NC. POSTMASTER: Send Address changes to the Sorth Carolina Register, 
PO Drawer 27447. Raleigh. NC 2761 1-7447 



NORTH CAROLINA ADMINISTRATIVE CODE CLASSIFICATION SYSTEM 



The North Carolina Administrative Code (NCAC) has four major subdivisions of rules. Two of these, titles and chapters, 
are mandatory: The major subdivision of the NCAC is the title. Each major department in the North Carolina executive 
branch of government has been assigned a title number. Titles are further broken down into chapters which shall be 
numerical in order. The other two. subchapters and sections are optional subdivisions to be used by agencies when 
appropriate. 



TITLE/MAJOR DIVISIONS OF THE NORTH CAROLINA ADMINISTRATIVE CODE 



TITLE 



DEPARTMENT 



LICENSING BOARDS 



CHAPTER 



1 


Administration 


Acupuncture 


1 


~) 


Agriculture 


Architecture 


2 


3 


Auditor 


Athletic Trainer Examiners 


3 


4 


Commerce 


Auctioneers 


4 


5 


Correction 


Barber Examiners 


6 


6 


Council of State 


Certified Public Accountant Examiners 


8 


7 


Cultural Resources 


Chiropractic Examiners 


10 


8 


Elections 


Emplovee Assistance Professionals 


11 


9 


Go\emor 


General Contractors 


12 


10 


Health and Human Services 


Cosmetic Art Examiners 


14 


II 


Insurance 


Dental Examiners 


16 


12 


Justice 


Dietetics''Nutrition 


17 


13 


Labor 


Electrical Contractors 


18 


I4A 


Crime Control & Public Safet)' 


Electrohsis 


19 


ISA 


En\ ironmeni and Natural 


Foresters 


20 




Resources 


Geologists 


21 


16 


Public Education 


Hearing Aid Dealers and Fitters 


22 


17 


Re\enue 


Landscape Architects 


26 


18 


Secretar. of State 


Landscape Contractors 


28 


19A 


Transportation 


Marital and FamiK Therap> 


31 


20 


Treasurer 


Medical Examiners 


32 


*21 


Occupational Licensing Boards 


Mid\vifer> Joint Committee 


33 


T) 


Administrative Procedures 


Mortuar. Science 


34 


23 


Communit\ Colleges 


Nursing 


36 


24 


Independent Agencies 


Nursing Home Administrators 


37 


25 


State Personnel 


Occupational Therapists 


38 


26 


Administrative Hearings 


Opticians 


40 


27 


NC State Bar 


Optometr\ 


42 






Osteopathic Examination & Reg. (Repealed) 


44 






Pastoral Counselors. Fee-Based Practicing 


45 






Pharmacx 


46 






Ph\sical Therap\ Examiners 


48 






Plumbing. Heating & Fire Sprinkler Contractors 


50 






Podiatr\' Examiners 


52 






Professional Counselors 


53 






Ps\cholog\ Board 


54 






Professional Engineers & Land Surveyors 


56 






Real Estate .Appraisal Board 


57 






Real Estate Commission 


58 






Refrigeration Examiners 


60 






Sanitarian Examiners 


62 






Social Work Certification 


63 






Soil Scientists 


69 






Speech & Language Pathologists & .Audiologists 


64 






Substance .Abuse Professionals 


68 






Therapeutic Recreation Certification 


65 






\eierinar\ Medical Board 


66 



Note: Title 2 1 contains the chapters of the various occupational licensing boards. 



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IN ADDITION 



This Section contains public notices that are required to be published in the Register or have been approved by the Codifier 
of Rules for publication. 



PUBLIC NOTICE 

Notice is hereby given that the North Carolina Wildlife Resources Commission is proposing to amend 15A NCAC lOB .0105, 
Hunting Regulations for Migratory Game Birds, to delineate the area of an experimental September teal season. Delineation of the 
area of the September teal season is necessary to properly manage this hunting season. This proposed rule change is based on the 
Federal FrameMwks for 1998-99 Early Hunting on Certain Migrator}- Game Birds published by the Department of the Interior. The 
Wildlife Resources Commission will consider this rule for temporary adoption, to become effective September 7, 1 998, at its August 
28, 1998 Commission meeting which will be held at the Charlotte Convention Center beginning at 9:00 AM. A news release will 
follow the adoption of the temporary rule. The North Carolina Wildlife Resources Commission has the authority to adopt this rule 
as a temporary rule pursuant to S.L. 1997-0403 following this abbreviated notice. A conforming amendment to the permanent rule 
will follow. 



13:4 NORTH CAROLINA REGISTER August 14, 1998 353 



I\ ADDITIO.\ 



U.S. Department of Justice 
Civil Rights Division 



EJ;DHH:TGL:par Voting Section 

DJ 166-012-3 PO Box 66128 

98-1812 Washington. DC 20035-6128 



Julv6. 1998 



Albert M. Benshoff. Esq. 

Cit> Attome> 

P.O.Box 1388 

Lumberton. North Carolina 28359-13S 

Dear Mr Benshoff: 



This refers to nvo annexations (Ordinance Nos. 1656 and 1657 (1988)) to the Cit\ of Lumberton in Robeson Count}-. North 
Carolina, submitted to the .Attome> General pursuant to Section 5 of the Voting Rights Act. 42 U.S.C. i973c. We recei\ed >our 
submission on Ma\' 18. 1998. 

The Altome\ General does not interpose an\ objection to the specified changes. Ho\\e\er. we note that Section 5 expressly 
pro\ ides that the failure of the Attome\ General to object does not bar subsequent litigation to enjoin the enforcement of the changes. 
See the Procedures for the Administration of Section 5 (28 C.F.R. 51.41). 



Sincere Iv. 



Elizabeth Johnson 
Chief. Votins Section 



354 NORTH CAROLIXA REGISTER August 14. 1998 13:4 



IN ADDITION 



U.S. Department of Justice 
Civil Rights Division 



EJ:GS:DCB:emr 

DJ 166-012-3 

98-1910 Washington. DC 20035-61 2h 



Voting Section 
PO Box 66128 



July 14, 1998 



Jesse L. Warren, Esq. 

City Attorney 

P.O. Box 3136 

Greensboro, North Carolina 27402-3 1 36 

Dear Mr. Warren: 

This refers to the annexation (Ordinance No. 98-59) and its designation to District 5 of the City of Greensboro in Guilford 
County, North Carolina, submitted to the Attorney General pursuant to Section 5 of the Voting Rights Act. 42 U.S.C. 1973c. We 
received your submission on May 28, 1998. 

The Attorney General does not interpose any objection to the specified changes. However, we note that Section 5 expressly 
provides that the failure of the Attorney General to object does not bar subsequent litigation to enjoin the enforcement of the changes. 
Seethe Procedures for the Administration of Section 5 (28 C.F.R. 51.41). 



Sincerely, 



Elizabeth Johnson 
Chief, Voting Section 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



355 



R ULE-MAKING A GENUA 



An agency may choose to publish a rule-making agenda which serves as a notice of rule-making proceedings if the 
agenda includes the information required in a notice of rule-making proceedings. The agency must accept comments 
on the agenda for at least 60 days from the publication date. Statutory reference: G.S. 1 50B-21.2. 



TITLE ISA - DEPARTMENT OF ENVIRONMENT AND NATURAL RESOURCES 

This agenda will serve as the notice of rule-making proceedings for the following rule-making bodies from August 15. 1998 through 
October 15. 1998: En\ironmental Management Commission - to rules codified in 15A NCAC 2D. 2H. 2L: Commission for Health 
Services - to rules codified in 15A NCAC 18C. 

DENR Regulator} Agenda Index - July 24, 1998 

AIR QUALITY 

APAf SUBJECT RULE CITATION # 

E26 1 2 11 2(r) Accidental Release 1 5 A NCAC 2D .2 1 00 

E2635 Toxic Air Pollutants ISA NCAC 2D .1104 & 2Q .0711 

E2636 Fugitive Dust 1 5 A NCAC 2D .0540/New Rule 

E2637 Toxic Air Pollutants ISA NCAC 2D .1 103. .1 104 and 2Q .0703. .071 1 

ENVIRONMENTAL HEALTH PUBLIC WATER SUPPLY 
APA= SUBJECT RULE CITATION # 

E2484 Water S\ stem Viabilit\/Capacit> 1 5 A NCAC 1 8C 

De\elopment 



WATER OUALITY 

APAf SUBJECT RULE CITATION # 

E2540 Classifications and Groundwater ISA NCAC 2L .0202 

Quality Standards (3S substances) 

and Biennial Re\iew 

WATER OUALITY LABOR.ATORY SERVICES 

APA= SUBJECT RULE CITATION # 

E2655 Laborator> Certification ISA NCAC 2H .0800 

DENR Regulaton Agenda - July 24, 1998 

APA ^: E2484 

SUBJECT: Water Svstem Viabilit> Capacity De\elopment 

RULE CITATION =': ISA NCAC 'l8C 

STATUTORY AUTHORITY: 

DIVISION SECTION: ENVIRONMENTAL HEALTH PUBLIC WATER SUPPLY 

DIVISION CONTACT: Jessica Miles 

DIVISION CONTACT TEL=: (919)733-2321 

DATE INITIATED; 6 16 98 

DUR^^TION OF RULE: Temporan. 10 198 

TYPE OF RULE: 

STAGE OF DEVELOPMENT: Concept Stage 

GOV LEVELS AFFECTED: None 

REASON FOR ACTION : 

EP.A's final Guidance on capacity de\elopment will not be released until .August of 1998. Beginning in Fiscal Year 1999 



356 NORTH CAROLINA REGISTER August 14, 1998 13:4 



i 



RULE-MAKING AGENDA 



(starting October 1, 1998), states without EPA approved programs will have withheld 20 percent of the Drinking Water State 
Revolving Fund (DWSRF) Capitalization Grant (20% = $2,560,000). If a state's capacity development program is approved 
bye EPA by October 1, 1999, the withheld amount will be returned. If a program is not approved by EPA by October 1, 
1999, the withheld amount will permanently revert back to EPA for redistribution to other states. An additional 20 percent 
will be withheld from each FY DWSRF allotment until the capacity development is approved. The Public Water Supply 
Section plans to use a stakeholder group to help guide rule development. Temporary rules are necessary to ensure EPA 
deadlines are met and millions of federal grant dollars are not forfeited. 
SCOPE/NATURE/SUMMARY : 

The rule has not been developed or drafted. There are water systems all across the nation that are unable to keep up with 
the increasingly complex set of federal laws and regulations governing mandatory water treatment, testing, and reporting. 
EPA is requiring all states to keep new such water systems from forming. The intent of the rule is to develop specific criteria 
to determine that proposed new community and non-transient non-community water systems are able to demonstrate 
technical, financial, and managerial capability with respect to each national primary drinking water regulation in effect, or 
likely to be in effect, for that water system. 

APA #: E2540 

SUBJECT: Classifications and Groundwater Quality Standards (35 substances) and Biennial Review 

RULE CITATION #: 15A NCAC 2L .0202 

STATUTORY AUTHORITY: G.S. 143-214.1; 143B-282(a)(2) 

DIVISION/SECTION: WATER QUALITY 

DIVISION CONTACT: David Hance 

DIVISION CONTACT TEL#: (9 19)7 15-6 189 

DATE INITIATED: 4/24/98 

DURATION OF RULE: Permanent 7/1/99 

TYPE OF RULE: 

STAGE OF DEVELOPMENT: Draft Rule Stage 

GOV LEVELS AFFECTED: None 

SCOPE/NATURE/SUMMARY : 

Specifies the maximum allowable concentration of substances in Class GA, GSA and GC groundwaters and procedures to 
establish standards for substances. 

APA #:E26]2 

SUBJECT: 1 12(r) Accidental Release 

RULE CITATION #: 15A NCAC .2100 

STATUTORY AUTHORITY: G.S. 143-215.3(a)(l); 143-215.107(a)(10) 

DIVISION/SECTION: AIR QUALITY 

DIVISION CONTACT: Thomas Allen 

DIVISION CONTACT TEL#: (919)733-1489 

DATE INITIATED: 6/22/98 

DURATION OF RULE: Permanent 7/1/00 

TYPE OF RULE: 

STAGE OF DEVELOPMENT: Concept Stage 

GOV LEVELS AFFECTED: State 

REASON FOR ACTION : 

To implement the accidental release prevention requirements for risk management programs of 40 CFR Part 68, which 
implements the requirements of Section 1 12(r) of the federal Clean Air Act. 

SCOPE/NATURE/SUMMARY : 

On June 20, 1996, the US Environmental Protection Agency promulgated rules to prevent accidental releases of regulated 
substances and to reduce the severity of accidents that do occur They were the results of worldwide concern about 
accidental chemical releases. The rules were promulgated under 40 CFR Part 68. The rules apply to stationary sources with 
processes that contain more than a threshold quantity of a regulated substance. These processes are divided into three 
categories based on the potential for offsite consequences associated with a worst-case accidental release, accident history, 
or subjectivity under OSHA's Process Safety Management Standard. Processes that have no potential impact on the public 
should have minimal requirements. For other processes, sources have to implement a risk management program that includes 
more detailed requirements for hazardous assessment, prevention, and emergency response. 

The State plans to implement the EPA's Risk Management and Chemical Accidental Release Prevention Program (referred 
to as "1 12(r)" from Section 1 12(r){7) of the federal Clean Air Act and further detailed in 40 CFR Part 68). The 1 12(r) 



13:4 NORTH CAROLINA REGISTER August 14, 1998 357 



R ULE-MAKING A GENOA 



program is aimed at reducing the potential for chemical accidental releases that may pose a risk to public health and the 
environment. 

Most likely the State rules will incorporate by reference the federal rules with little or no changes. These rules will apply 
to both facilities required to be permitted under Title V of the federal Clean Air Act (Title V facilities) and to facilities that 
are not covered under Title V. 

APA #: E2635 

SUBJECT: Toxic Air Pollutants 

RULE CITATION #: 15A NCAC 2D .1 104 & 2Q .071 1 

STATUTORY AUTHORITY: G.S. I43-215.3(a)(l); 143-2I5(a)(3),(4),(5); 143-215.108; 143-282; S.L. 1989. C. 168, S.45 

DIVISION/SECTION: AIR QUALITY 

DIVISION CONTACT: Thorn Allen 

DIVISION CONTACT TEL#: (919)733-1489 

DATE INITIATED: 7/9/98 
. DURATION OF RULE: Permanent 

TYPE OF RULE: 

STAGE OF DEVELOPMENT: Concept Stage 

GOV LEVELS AFFECTED: None 

REASON FOR ACTION : 

To amend the air toxic rules to add acceptable ambient levels for methylene diphenyl isocyanate (MDI). hexamethylene-I, 
6-diisoc\anate (HDl), and acrvlamide. 

SCOPE/NATURE/SUMMARY : 

The Secretary's Scientific Advisory Board (SAB) has recommended acceptable ambient levels for methylene diphenyl 
isocyanate (MDI) of 0.00036 mg/m\ 24-hour average. hexamethylene-I. 6-diisocyanate (HDI) of 09.00003 mg/m\ 24-hour 
average and aery lamide of 0.03 mg'm'. 24-hour average and 0.00023 mg/m'. annual. Rule 15A NCAC 2D .1 104, Toxic Air 
Pollutant Guidelines, would be amended to add acceptable ambient levels for these three toxic air pollutants. Rule 15A 
NCAC 2Q .071 1. Emission Rates Requiring a Permit, would also be amended to add corresponding toxic permit emission 
rates. 

APA «: E2636 

SUBJECT: Fugitive Dust 

RULE CITATION »: 15A NCAC 2D .0540/"New Rule 

STATUTORY AUTHORITY:G.S. 143-215.3(a)(l); 143-107(a)(5); 143-215. 108(c)(7) 

DIVISION/SECTION: AIR QUALITY 

DIVISION CONTACT: Thom Allen 

DIVISION CONTACT TEL#: (919)733-1489 

DATE INITIATED: 7/9/98 

DURATION OF RULE: Permanent 

TYPE OF RULE: 

STAGE OF DEVELOPMENT: Concept Stage 

GOV LEVELS AFFECTED: Local State 

REASON FOR ACTION : 

To adopt a new rule to control the emissions of fugitive dust. 

SCOPE/NATURE/SUMMARY : 

On December 1. 1997. the Environmental Management Commission (EMC) held a public hearing on the adoption of a new 
rule 15A NCAC 2D .0540. Particulates fi^om Fugitive Non-Process Dust Emission Sources. The proposed rule applied to 
all industries. After receipt of public comments, the EMC revised the rule. The rule adopted b\l he EMC limited its 
coverage to four industries, viz., hot mix asphalt plants, mica or feldspar processing plants, sand, gravel, or crushed stone 
operations, and lightweight aggregate processes. The EMC also directed teh Division of Air Quality to develop a rule to 
control fugiti\e dust from sources not covered under the new rule. 

Several options could be used to address fugitive dust emissions from these other sources. The current rule could be 
amended to extend its coverage to other sources of non-process fugitive dust. (The currect rule is a complaint driven rule. 
Two complaints supported b\ physical evidence are proof that a fugitive dust problem exists. The facility causing the dust 
problem has to develop and implement a best management plan to control non-process fugitive dust.) Another option is to 
use visible emissions as evidence of a fugitive dust problem. A combination of complaints and visible emissions could be 
used. Also, the neu rule could be limited to non-process fugitive emissions, or it could cover both non-process and process 



358 yORTH CAROLINA REGISTER Ausust 14. 1998 13:4 



R ULE-MAKING A GENDA 



fugitive emissions. 

APA #: E2637 

SUBJECT: Toxic Air Pollutants 

RULE CITATION #: 15A NCAC 2D .1103, .1 104 and 2Q .0703, .0711 

STATUTORY AUTHORITY: G.S. 143-215.3(a)(l); 143-215(a)(3),(4),(5); 143-215.108; 143-282; S.L. 1989, C. 168, S.45 

DIVISION/SECTION: AIR QUALITY 

DIVISION CONTACT: Thorn Allen 

DIVISION CONTACT TEL#: (919)733-1489 

DATE INITIATED: 7/9/98 

DURATION OF RULE: Permanent 

TYPE OF RULE: 

STAGE OF DEVELOPMENT: Concept Stage 

GOV LEVELS AFFECTED: None 

REASON FOR ACTION : 

To amend the air toxic rules to revise acceptable ambient levels for chromium (VI) compounds. 

SCOPE/NATURE/SUMMARY : 

The Manufacturers and Chemical Industry Council of North Carolina (MCIC) has requested that the air toxic rules for 
chromium (VI) compounds be revised. MCIC requests that the several chromium (VI) compounds listed in the current rules 
be combined into 3 groups. Group 1 would contain bioavailavle chromate pigments, which includes calcium chromate, 
strontium chromate, and zinc chromate. The acceptable ambient level for this group of compounds would be 8.3xlO*mg.m\ 
Group 2 would contain soluble chromate sales, which includes ammonium chromate, ammonium dichromate, chromic acid, 
potassium chromate, potassium dichromate, sodium chromate. and sodium dichromate. The acceptable ambient level for 
this group would be 6.2x1 0~'mg/m\ Group 3 would contain all the chromium (VI) compounds not included in Group 1 or 
Group 2. Its acceptable ambient level is 8.3x1 0"mg/m'. The compounds in these three groups should be regulated on a 
chromium (VI) equivalent basis and not on the specific chromium compound basis. The Division of Air Quality has 
reviewed the records of the Secretary's Scientific Advisory Board and basically concurs with MCIC's request. 

The implementation of this request would require amending Rule 15 A NCAC 2D .1 104, Toxic Air Pollutant Guidelines, 
to revise the acceptable ambient levels for the chromate compounds and amending Rule 15A NCAC 2Q .071 1, Emission 
Rates Requiring a Permit, to revise the corresponding toxic permit emission rates. Also rules 1 5 A NCAC 2D . 1 1 03 and 2Q 
.0703 may also need amending to add definitions for bioavailable chromate pigments and soluble chromate salts. 

APA #: E2655 

SUBJECT; Laboratory Certification 

RULE CITATION #: ISA NCAC 2H .0800 

STATUTORY AUTHORITY: G.S. 143-215.3(a)(l);143-215.3(a)(10) 

DIVISION/SECTION: WATER QUALITY/LABORATORY SERVICES 

DIVISION CONTACT: James W. Meyer 

DIVISION CONTACT TEL#: (919)733-3908 

DATE INITIATED: 7/23/98 

DURATION OF RULE: Permanent 4/1/99 

TYPE OF RULE: 

STAGE OF DEVELOPMENT: Draft Rule Stage 

GOV LEVELS AFFECTED: Local 

REASON FOR ACTION : 

The present fee collection schedule is not adequate to support the program. To date, salaries have risen 24% for employees; 

travel expenses have risen 25-30%; operation costs for materials, supplies, equipment maintenance, etc. have risen 25-30%. 

The ability to keep the program functional with these cost increases under the old fee schedule has become impossible, which 

has prompted the proposed action. 
SCOPE/NATURE/SUMMARY : 

The purpose of these Rules is to set out certification criteria for laboratory facilities performing any tests, analyses, 

measurements, or monitoring required under Article 21 of G.S. 143 or any rules adopted thereunder, and to establish fees 

for certification. 



13:4 NORTH CAROLINA REGISTER August 14, 1998 359 



RULE-MAKING PROCEEDINGS 



A Notice of Rule-making Proceedings is a statement ofsuhject matter of the agency's proposed rule making. The agency- 
must publish a notice of the subject matter for public comment at least 60 days prior to publishing the proposed text of a 
rule. Publication of a temporary rule sen-es as a Notice of Rule-making Proceedings and can be found in the Register under 
the section heading of Temporary Rules. .4 Rule-making Agenda published by an agency serves as Rule-making Proceedings 
and can be found in the Register under the section heading of Rule-making Agendas. Statutory reference: G.S. 150B-21.2. 



TITLE 1 -DEPARTMENT OF ADMINISTRATION 

CHAPTERS -PURCHASE AND CONTRACT 

A Totice of Rule-making Proceedings is hereby given by the 
1 y Department of .Administration in accordance with G.S. 
I5UB-2I.2. The agency shall subsequently publish in the 
Register the text of the rule(s) it proposes to adopt as a result of 
this notice of rule-making proceedings and any comments 
received on this notice. 

Citation to Existing Rules AfTected by this Rule-Making: 

/ NCAC 5.4 through 5D. Other rules ntay be proposed in the 
course of the rule-making process. 

Authority for the rule-making: G.S. 143-3: I43-3A: 143-3C 

Statement of the Subject Matter: To modify the rules relating 
to State procurement. State Surplus Property, and considtant 



Reason for Proposed Action: S.L. 199~-412 requires the 
changing of certain rules relating to the increase in purchasing 
benchmarks and delegation limits for universities and agencies. 
In addition, there is a need to change clarify other rules as they 
pertain to the university and agency purchasing policies and 
procedures as a result of the increase. Further modifications 
are needed to improve the procurement and disposition 
processes, including those for procurement of consultant 
ser\'ices. and to provide more flexibility for the universities and 
agencies. 

Comment Procedures: Any person interested in making 
written or verbal comment to these proposed rule changes 
should submit such comment to R. Glen Peterson. General 
Counsel. N.C. Department of .Administration. 116 West Jones 
Street. Raleigh. \C 2"603-8003: telephone (919) -33-'7232:fax: 
(919) ^33-9571: email: glen jjeterson a mail. doa. state. nc. us. 



■K vc yt yt -K 



CHAPTER 30 - STATE CONSTRUCTION 

A Totice of Rule-making Proceedings is hereby given by the 

J. V State Building Commission in accordance with G.S. 
1508-21. 2. The agency shall subsequently publish in the 
Register the text of the rule(s) it proposes to adopt as a result of 
this notice of rule-making proceedings and any comments 
received on this notice. 

Citation to Existing Rules Affected by this Rule-Making: 



/ NCAC 30F . 0305. Other rules may be proposed in the course 
of the rule-making process. 

Authority for the rule-making: G.S. 143-135.26(4) 

Statement of the Subject Matter: This revision will modify 
the State Building Commission's contractor evaluation 
procedures to allow for alternatives to disqualification as 
recommendations from the Commission's review panel. 

Reason for Proposed Action: This proposal was requested by 
members of the State Building Commission who had expressed 
concern that the present rules have no intermediate action in 
cases where some doubts are raised in the contractor evaluation 
process. This proposal allows the Commission to provide a 
warning to the contractor rather than disqualify the contractor 
from bidding whatsoever Under the present procedures, if the 
panel finds that the contractor should be removed from prebid 
disqualification, the records are purged and the contractor 
starts out with a new record. Under the proposed revision, the 
records will be retained. 

Comment Procedures: All written comments should be made 
to Dan R. Murray. State Construction Office. 301 North 
Wilmington Street. Education Building. Suite 450. Raleigh. 
North Carolina 2'601-282'. telephone (919/ 733-7962. 



XXWWXXWTCTTltW 



K W W W W W W 



CHAPTER 35 - STATE EMPLOYEES 
COMBINED CAMPAIGN 

A Totice of Rule-making Proceedings is hereby given by the 

J. V Department of .Administration in accordance with G.S. 
150B-21.2. The agency shall subsequently publish in the 
Resister the text of the rule(s) it proposes to adopt as a result of 
this notice of rule-making proceedings and any comments 
received on this notice. 

Citation to Existing Rules AfTected by this Rule-Making: 

1 NCAC 35 .0101. .0103. .0202. .0304. .0308. Other rules may 
be proposed in the course of the rule-making process. 

Authority for the rule-making: G.S. 143-3.3. 143B-10. 

Statement of the Subject Matter: The State Employees 
Combined Campaign wishes to provide clear rules as to the 
responsibilities of local campaign organizations and establish 
clear requirements for consideration of applicants to be local 
campaign organizations. Other technical changes are also 
necessary to update the Campaign's rules. 



360 



NORTH CAROLINA REGISTER 



August 14, 1998 



13:4 



RULE-MAKING PROCEEDINGS 



Reason for Proposed Action: The Campaign has grown 
greatly in recent years and many charitable organizations wish 
to participate in the campaign. More detailed application 
procedures hcn'e become necessaiy, and clearer definition of 
local responsibilities are now desirable. Small organizations 
needed flexibility in providing financial information, which is set 
out in the proposed rules, along with technical changes. 

Comment Procedures: All written comments should be made 
to R. Glen Peterson, General Counsel, Department of 
Administration. 116 West Jones Street, Raleigh, North Carolina 
27603-8003. telephone (919) 733-7232. 



TITLE 15A - DEPARTMENT OF ENVIRONMENT 
AND NATURAL RESOURCES 

CHAPTER 7 - COASTAL MANAGEMENT 

A Totice of Rule-making Proceedings is hereby given by the 
1 V DENRCoaslal Resources Commission in accordance with 
G.S. 150B-21.2. The agency shall subsequently publish in the 
Resister the text of the rule(s) it proposes to adopt as a result of 
this notice of rule-making proceedings and any comments 
received on this notice. 

Citation to Existing Rules Affected by this Rule-Malcing: 

15A NCAC 7M .0401 -.0403. Other rules may be proposed in 
the course of the rule-making process. 

Authority for the rule-making: G.S. 113A-24: 11 3A-1 02(b): 
113.4-107 

Statement of the Subject Matter: The NC Coastal Resources 
Commission proposes to make minor amendments to the NC 
Coastal Energy Policies to more clearly address potential effects 
of offshore drilling on fisheries habitat and seabirds, and to 
address the potential effects of severe weather conditions on the 
safety of drilling operations. 

Reason for Proposed Action: A revicM' of the current rules 
and scientific literature identified a need to make minor 



amendments to the energy policies to protect key fisheries 
habitat and endangered seabirds from potential impacts from 
offshore development of energy resources. 

Comment Procedures: Contact Kim Crawford, NC Division 
of Coastal Management, PO Box 27687, Raleigh, NC 27611 - 
7687, (919) 733-2293. 



TITLE 19A - DEPARTMENT OF 
TRANSPORTATION 

CHAPTER 2 - DIVISION OF HIGHWAYS 

A Totice of Rule-making Proceedings is hereby given by the 
1 V Department of Transportation - Division of Highways in 
accordance with G.S. 1503-21. 2. The agency shall subsequently 
publish in the Resister the text of the rule(s) it proposes to adopt 
as a result of this notice of rule-making proceedings and any 
comments received on this notice. 

Citation to Existing Rules AiTected by this Rule-Making: 

19A NCAC 02E . 022 1-. 0222. Other rules may be proposed in 
the course of the rule-making process. 

Authority for the rule-making: G.S. 136-89.56: 136-137: 
136-139: 143B-346: 143B-348: 143B-350(f) 

Statement of the Subject Matter: Rules set conditions, 
parameters, and fees for the Logo Signing Program. 

Reason for Proposed Action: NC DOT's Internal Audit staff 
conducted an audit of the Logo Sign Program and recommended 
that the fees be increased. The logo program is self-sustaining 
and fees charged pay for new projects and maintenance on 
existing signs. Fees for the program must be adjusted 
periodically. Logo fees hcn'e not been revie^'edfor 'years. 

Comment Procedures: Any interested person may submit 
written comments on the proposed rules by mailing the 
comments to Emily Lee. NC DOT, PO Box 25201. Raleigh, NC 
27611, bv December 15, 1998. 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



361 



PROPOSED RULES 



This Section contains the text of proposed rules. At least 60 days prior to the publication of text, the agency published a 
\otice of Rule-making Proceedings. The agency must accept comments on the proposed rule for at least 30 days from the 
publication date, or until the public hearing, or a later date if specified in the notice by the agency. The required comment 
period is 60 days for a rule that has a substantial economic impact of at least five million dollars fS5. 000, 000). Statutory 
reference: G.S I50B-2L2. 



TITLE 15A - DEPARTMENT OF ENVIRONMENT 
AND NATURAL RESOURCES 

Notice is hereby given in accordance with G.S. 150B-2L2 
that the Department of Environment and Natural 
Resources intends to adopt the rulels) cited as 15.4 SC.4C IN 
.0101:0103. .0201-.0203. .0301-.0304. .040I-.0403. .0501- 
.0503. .0601:0606. .0-01-.0-'05. .0801:0802. .0901-.0902. 
Notice of Rule-making Proceedings was published in the 
Register on February 16. 1998. 

Proposed Effective Date: .April 1. 1999 

A Public Hearing will be conducted at 9:00 a.m. on August 31. 
1998 at the .Archdale Building. Ground Floor Hearing Room. 
512 N. Salisbury Street. Raleigh. NC 27604. 

Reason for Proposed Action: To establish procedures and 
criteria for making low interest loans from the Drinking Water 
State Re\-olving Fund iDWSRFj. 

Comment Procedures: Contact Sid Harrell at (919) 715-3216 
or at Public Water Supply Section. PO Box 29536. Raleigh. NC 
2 7626-0536. End of comment period is September 30. 1998. 

Fiscal Note: These Rules. 15A NCAC IN .0101-.0102 do not 
affect the expenditure or distribution of State funds subject to the 
Executive Budget Act. Article 1 of Chapter 143. These Rules. 
15A NCAC IN .0103. .0201:0203. .0301:0304. .0401:0403. 
.0501:0503. .0601:0606 .0-01:0-^05. .0801:0802. .0901- 
.0902 do affect the expenditure or distribution of Stale funds 
subject to the Executive Budget .Act. Article 1 of Chapter 143. 



(2) "Division" means the Division of Environmental 
Health. Department of Environment and Natural 
Resources: 



Q} 



iAl 



15J 



i6j 



"Fund" means the Drinking Water Treatment 
Revolving Loan fund established by G.S. 159G-5(d): 
"Intended Use Plan" means an annual plan to identify 
the proposed uses of the amount available in the state 
revolving fund; 



"MCL" means maximum contaminant level which is 
the permissible level of a contaminant in water which 
is delivered to anv user of a public water system: 
"Receiving agency" means the Division of 
Environmental Health. 



Authority G.S 159G-5: 159G-15. 

.0103 APPLICABLE PROCEDURES 

Loans from the Fund will be made m accordance with 
guidelines found in the "Drinking Water State Revolving Fund 
Program Guidelines." published by the United States 
En\ironmental Protection Agenc\. Office of Water, on February 
28. 1997 (EPA 816-R-97-005) which is hereby incorporated bv 
reference including an\ subsequent amendments and additions. 
This material js available for inspection at the Department of 
Environment and Natural Resources. Division of Environmental 
Health. 2728 Capital Boulevard. Raleigh. North Carolina. Free 
copies ma\ be obtained from the U.S. Environmental Protection 
Agenc\ b\ telephoning 1 -800-426-479 1 . TTie guidelines are also 
a\'ailable on-line at 
http: \^\^^^.epa.gov.OG\^"DWregS' Intro. html. 

Authorit\- G.S 159G-5: 159G-I5. 



CHAPTER 1 - DEPARTMENTAL RULES 



SECTION .0200 - AVAILABILITY OF LOANS 



SUBCHAPTER IN - DRINKING WATER 
TREATMENT FUND RULES 

SECTION .0100 - GENERAL PROVISIONS 

.0101 PURPOSE 

Loans for public water sNstems from the Drinking Water 
Treatment Re\oK ing Loan fund established by G.S. 159G-5(d) 
shall be made in accordance w'nh this Subchapter. 

.Authority G.S. 159G-5: I59G-15. 

.0102 DEFINITIONS 

The follow ing definitions shall appK to this Subchapter: 
( 1) "Act" means the N.C. Drinking Water Act. G.S. 
130A-311 et. seq: 



.0201 AVAILABILITY OF LOANS 

(a) Loans are available onK for projects that appear on the 
state approved intended use plan submitted to the U.S. 



Environmental Protection Agency and that are in compliance 
with the requirements of this Subchapter. 

(b) During an\ fiscal \ear 15 percent of the annual allocation 
shall be available soleK for providing assistance to public water 
systems which regularh serve fewer than 10.000 persons to the 
extent such funds can be obligated for eligible projects. 

(c) During an\ fiscal \ear a maximum of five percent of the 
annual allocation ma\ be used for loans for project planning 
purposes onl\. 

Authorities. 159G-5: 159G-15. 

.0202 LOAN RESTRICTIONS 



362 



.\ORTH CAROLIXA REGISTER 



August 14, 1998 



PROPOSED RULES 



(a) Loans shall not be used for the acquisition of real property 
or interests therein, unless the acquisition is integral to a project 
authorized under this Subchapter and the purchase is from a 
willing seller. 

(b) Except as provided in Paragraph (c) of this Rule no 
assistance shall be provided to a public water system that does 
not have the technical, managerial, and financial capacity to 
ensure compliance with the requirements of the Act or to a 
public water system that is in significant non-compliance with 
any requirement of the Act or with a variance authorized under 
the Act as evidenced by administrative penalty, administrative 
order or court action against the water system. A determination 
of technical, managerial, and financial capacity will be based 
upon a review of finances, compliance with applicable public 
health, environmental and utility laws, and the experience and 
certification level of the water system operator as evidenced by 
the submission of a business plan as required by Section .0400 
of this Subchapter. 

(c) A public water system in significant non-compliance with 
the Act may receive assistance if the assistance will ensure 
compliance with the Act. A public water system that does not 
have technical, managerial, and financial capacity may receive 
assistance if the owner or operator shall agree to undertake 
feasible and appropriate changes in operation of the water 
system that will ensure the system will achieve technical, 
managerial, and financial capacity over the long-term. 

(d) Each applicant shall establish a dedicated source of 
revenue or demonstrate that there is adequate security for 
repayment of the loan. 

(e) Funding will be limited to the most cost-effective solution 
for the compliance or public health problem identified in a 
proposed project. 

(D Funding will be limited to the eligible portions of a project 
containing ineligible segments. 

(g) Funding shall not be available for federally owned public 
water systems. 

Authority- G.S. I59G-5: 159G-15. 

.0203 ADMINISTRATIVE EXPENSES 

Agreement to a debt instrument by a loan applicant shall 
include payment of a two percent closing fee which is an 
ineligible project cost. These monies shall accrue to be used 
only for the reasonable costs of administering the Fund. 

Author it}- G.S. 159G-5: 159G-15. 

SECTION .0300 - ELIGIBILITY REQUIREMENTS 

.0301 DETERMINATION OF ELIGIBILITY 

(a) Eligibility of applicants shall be determined in accordance 
with G.S. 159G-3(2)andG.S. I59G-9. 

(b) Applications shall be returned to ineligible applicants. 

(c) An application may not be filed after the award of a 
construction contract on a project, except when an applicant is 
subject to an administrative order issued by tlie Division or a 
legally enforceable deadline. 



Authority G.S. I59G-5; 159G-15. 

.0302 ELIGIBLE PROJECTS 

(a) Projects that will facilitate compliance with the North 
Carolina Drinking Water Act or federal Safe Drinking Water Act 
or further health protection under the criteria of Rule .0602 of 
this Subchapter shall be eligible for funding under this 
Subchapter. Eligible projects include those that: 

(1) Rehabilitate or develop sources to replace 
contaminated sources of drinking water; 

(2} Install or upgrade treatment to meet state or federal 
regulations; 

(3) Install or upgrade eligible storage to prevent entry of 
microbiological contamination; 

(4) Install or replace transmission or distribution pipes to 
prevent contamination; 

(5) Consolidate or restructure water systems; or 

(6) Purchase capacity in another water system. 

(b) Types of projects which are not eligible for funding are: 

(1) Dams or rehabilitation of dams; 

(2) Water rights, except if the water rights are owned by 
a system that is being purchased through 
consolidation as part of a capacity development 
strategy; 

(3) Reservoirs, except for finished water reservoirs and 
those reservoirs that are p art of treatment process and 
are located on tlie property where the treatment 
facility is located; 

(4) Laboratory fees for monitoring; 

(5) Operation and maintenance expenses; 

(6) Projects needed mainly for fire protection; or 

(7) Projects primarily intended to serve future growth. 

A uthority G. S. 1 59G-5: 1 59G- 1 5. 

.0303 ELIGIBLE PROJECT COSTS 

(a) Project construction costs eligible for a loan under this 
Subchapter are limited to: 

(1) Planning, including system and needs assessment, the 
preparation of a local water supply plan and the 
preparation of a business plan; 

(2) Environmental assessment reports, including all 
federal cross-cutters; 

(3) Design; 

(4) Construction; 

(5) Legal, fiscal, and administrative costs; 

(6) Contingency costs; and 

(7) Land acquisition integral to the project. 

(b) Loans may be up to 100 percent of allowable construction 
project costs. 

(c) Loans made for project planning purposes only are 
available for acute, immediate, and chronic health hazards as 
determined in Rule .0602 of this Subchapter. 

Authority G.S 159G-5: 159G-15. 

.0304 MAXIMUM LOAN AMOUNT 

The maximum principal amount of loan commitment from any 



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363 



PROPOSED RULES 



fiscal year's allocation made to an applicant shall be three million 
dollars ($3,000,000.00). except that the maximum amount of 
loan commitment fi'om any fiscal year's allocation for a project 
planning purposes only loan shall be twenty-five thousand 
dollars ($25,000). 



.0501 PRIORITY REVIEW PERIOD 

The priority review period shall be from October 1 until June 
30 of the following year, except that for FY 96/97 Funds it shall 
be from February 14 until September 30. 1998. 



Authorin'G.S. 159G-5: 159G-I5. 



Authority G.S. 159G-5: 159G-15. 



SECTION .0400 - APPLICATIONS 

.0401 FILING DEADLINES 

Applications for loans shall be postmarked or delivered to the 
Division of Environmental Health on or before September 30 of 
each year in order to be approved for loan funds available during 
the following fiscal year, except February 13. 1998. for FY 
96/97 SRF funds. 

Authority- G.S. 159G-5: 159G-15. 

.0402 APPLICATION PROCEDURES 

(a) Applications for loans shall be submitted on forms 
provided bv the Division and shall be accompanied by all 
documents such as the Preliminary Engineering Report (PER), 
assurances, and other information required by the instructions 
for completing and filing the applications. Information 
concerning any grant or loan funds from an\ other source for 
which the applicant has applied shall be disclosed on the 
application. 

(b) Every application shall be accompanied by an adopted 
resolution or other documentation as required by G.S. 159G- 
9(4). The resolution or documentation shall be certified or 
attested to as a true and correct copy as adopted. 

(c) An applicant shall furnish additional information upon the 
request of the Division. 

(d) A project shall not receive a priority rating unless the 
application contains sufficient information on the day of rating 
for the receiving agency to review and assign priority points in 
accordance with Section .0600 of this Subchapter. 

(e) An application may be withdrawn from consideration 
upon request of the applicant but if resubmitted shall be 
considered as a new application. 

Authority- G.S. I59G-5: 159G-15. 

.0403 PROJECT SCHEDULE AND RESOLUTION 

Every application shall be accompanied by a project schedule 
specifying dates for milestone events including: 

business plan submittal as required bv the Division: 



ill 
t2J 
ill 

t6J 



plans and specifications submission and approval; 
a rate schedule submittal : 
bid opening and award: 
construction start: and 
project completion. 



.0502 ASSIGNMENT OF PRIORITIES 

(a) During each review period the Division will assign a 
priority rating to each eligible application for inclusion in the 
state intended use plan: the priority rating shall be determined 
in accordance with the rating criteria and points contained in 
Section .0600 of this Subchapter. 

(b) The Division may exercise discretionary authority to 
establish a priority rating when two or more applications receive 
the same number of priority points. The project receiving the 
most points for public health and compliance shall receive the 
greater priority. If the public health points awarded the projects 
are equal, the project with the smaller population shall receive 
the greater priority. If points are still equal, the project with the 
greatest financial need as determined m accordance with Rule 
.0605 of this Subchapter shall receive the higher ranking. 

(c) Only the eligible portions of a project containing ineligible 
segments will receive a priority rating. 

(d) The Division may assign a different priority rating to each 
substantially independent p art of a proposed project. 

(e) Any applications that are not awarded assistance during a 
review period will be held over and considered for a second 
review in accordance with G.S. 159G- 10(d). 

Authority- G.S 159G-5: 159G-15. 

.0503 INTENDED USE PLAN 

A state intended use plan containing the priorits' rating of each 
eligible project yvill be prepared by the Division. The intended 
use plan yvill include a comprehensive priority list identif\'ing 
which projects are intended to be fiinded jn the current y ear and 
in future years. The projects that are expected to be funded in 
the current year will be so noted. The priority rating of eligible 
projects will be published and an opportunity for public hearing 
will be provided before funds are awarded. 

Authority G.S. I59G-5: I59G-15. 

SECTION .0600 - PRIORITY CRITERIA 

.0601 GENERAL CRITERIA 

(a) In determining the priority to be assigned each eligible 
application the Division will consider whether the project yvill: 



ill 

12} 



Authority G.S 159G-5: 159G-I5. 

SECTION .0500 - REVIEW AND ASSIGNMENT OF 
PRIORITIES 



Address the most serious risk to human health. 
Facilitate compliance with the N.C. Drinking Water 
Act or the federal Safe Drinking Water Act, and 
(3) Assist systems most in need on a per household basis, 
(b) The total priorin points received will be the sum of all 
points awarded for each categorical element. 

Authorit^- G.S 159G-5: 159G-15. 



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.0602 PUBLIC HEALTH AND COMPLIANCE 

Public health and compliance points may be awarded to a 
project based on the following criteria. A proposed project shall 
be necessary to facilitate compliance with the N.C. Drinking 
Water Act or the federal Safe Drinking Water Act and to 
alleviate the type of public health concern for which points are 
awarded. A project will receive only points in the highest sub- 
category for which it may qualify': 

(1) Acute/Imminent Health Hazards. A maximum of 1 50 
points will be awarded to projects that propose to 
eliminate any one or more of the following acute. (4) 
ongoing health hazards to the consumer: 

(a) Projects that address documented nitrate, nitrite 
or fecal coliform MCL violations, or 
contaminant levels in drinking water which 
constitute acute health risks as defined in 40 
C.F.R 141.32(a)(l)(iii) which is incorporated 
by reference at 1 5 A NCAC 1 8C. 1 523; or 

(b) Projects that eliminate any contaminant in the 
public water system that poses an acute risk or 
imminent hazard to public health as determined 
by the State Health Director or a health risk 
assessment fi-om the Division of Epidemiology. 
Department of Health and Human Services in 
accordance with G.S. 130A-2(3). 

(2) Immediate Health Hazards. A maximum of 100 
points will be awarded to projects that propose to 
eliminate any one or more of the following immediate 
health hazards to the consumer: 

(a) Projects that address surface v\ater treatment 
technique violations occurring for two or more 
consecutive months: 

(b) Projects that resolve any microbiological MCL 
problems for a water system \\ ith three or more 
microbiological MCL violations during the £5} 
previous 12 months; 

(c) Projects that propose filtration for a surface 
water source or for a well that is determined to 
be under the direct influence of surface water 
by the Department that does not currently have 
filtration; 

(d) Projects that address the inability of a public 
water system to inactivate giardia and viruses 
in accordance with 1 5 A NCAC 1 8C .200 1 ; or 

(e) Projects that address documented recurrent 
water outages or low pressure below the 
requirements of 1 5 A NCAC 1 8C .090 1 . Only 
problems that affect human consumption of 
drinking water will be considered for award of 
points under this criteria. 

(3) Chronic Health Hazards. A maximum of 60 points 
will be awarded to projects that propose to eliminate 
any one or more of the following chronic health 
hazards to the consumer: 

(a) Projects that address exceedances of the lead 
and copper action levels under 15A NCAC 
18C.1507; 

(b) Projects that address violations of inorganic or 



organic chemical or contaminant MCLs under 
15ANCAC 18C.1510. .1517. and.1518; 
(c) Projects that address violations of radiological 
contamination MCLs under 15A NCAC 18C 
.1520 and. 1521; or 
£d} Projects that address a chronic health hazard as 
determined by the State Health Director or a 
health risk assessment from the Division of 
Epidemiology. Department of Health and 
Human Services. 
Potential Health Hazards. A maximum of 40 points 
will be awarded to projects that propose to eliminate 
any one or more of following potential health hazards 
to the consumer: 

(a) Projects that address low chlorine residuals in 
the distribution system; 

(b) Projects that address periodic violations of an 
MCL; 

(c) Projects for line installation or extensions to 
areas with poor water quality or limited 
quantity; 

(d) Projects to develop new sources of water, to 
augment existing sources, or to expand 
treatment capacity to meet current demand 
when the average daily demand for the 
previous 12 months equals or exceeds the 
available water supply as calculated in local 
water supply plans prepared in accordance with 
G.S. 143-355(1) or the maximum day demand 
for the previous 12 months equals or exceeds 
the approved water treatment plant design 
capacity; or 

(e) Projects to provide disinfection for a system 
that currently does not have disinfection. 

System Improvements. A maximum of 20 points yvill 
be awarded for projects that will provide any one or 
more of the following general system improvements 
when needed for public health purposes: 

(a) Projects that replace water supply production 
or treatment equipment that is undersized- 
malfunctioning or has exceeded its useful life; 

(b) Projects that replace undersized or leaking 
water lines; 

(c) Projects that address other yvater quality 
concerns such as iron, manganese, taste, and 
odor; 



£d} 



(e} 

m 



Projects to bring existing facilities to current 
design standards which affect yvater quality 
such as treatment, chemical storage and 
application, pumping facilities, finished 
storage, distribution systems; 
Projects that eliminate dead ends and provide 
looping in a distribution system; 
Projects that increase water storage capacity ; 
Projects to develop new sources of yvater. to 
augment existing sources, or to expand 
treatment capacity to meet current demand 
when the average daily demand for the 



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365 



PROPOSED RULES 



pre\ious 12 months exceeds 80 percent of the a\ailable water 
suppl\ as calculated in local water supply plans prepared m 
accordance with G.S. 143-355(1) or the maximum da\ demand 
for the pre\ ious 1 2 months exceeds 80 percent of the approved 
w ater treatment plant design capacin : or 

(h) Projects for installation or upgrade of v^ater 
treatment plant waste disposal facilities. 

Aulhorin-G.S. I59G-5: 159G-15. 

.0603 CONSOLIDATION 

A maximum ot" K) points will be awarded m thjs categorical 
element for projects that propose to impro\e water s\stem 
reliabilin b\ interconnecting with an existing water system, by 
purchasing s\ stems in whole or in part, or b\ purchasing water 
capacity from other s\ stems, as follows: 

( 1) Projects that propose consolidation to provide water 
service to an existing communirs whose water suppl\ 
cannot meet the rules governing public water systems 
at 15ANCAC 18C. 10 points: 

(2) Projects that propose consolidation of existing water 
systems v\ill be awarded fi\e points: 

(3) Projects where consolidation is not physically 
feasible, five points. 

AiithohnG.S. 159G-5: 159G-15. 

.0604 RELIABILITY 

A maximum of five points will be avsarded in this categorical 
element to projects that propose to increase the reliabilit\ of the 
y\ater system: points may be awarded for both Items ( 1 ) and (2) 
of this Paragraph up to the maximum, as follows; 

( 1 ) Projects that pro\ ide redundancy to critical treatment 
or deli\ery functions, such as interconnection, three 
points: 

(2) Projects that provide emergency backup electrical 
power source, three points if not awarded points m 
Item ( 1 ) of this Paragraph. 

AuthorinG.S. 159G-5: 159G-I5. 

.0605 AFFORDABILITY 

Points for afFordabihty will be determined by comparing the 

projected monthly residential user cost at the completion of the 

project with the median household income (MHl). User cost 

shall be calculated from y\ater rates based on a maximum of 

4.500 gallons. The median household income shall be 

determined in thie service area of thie water system. If median 

household income data is not available for the serv ice area, data 

from the nearest c omparable community area shall be used. The 

Di\ision may use county-wide median household income data if 

data for the serv ice area or nearest comparable community area 

are not available. Points will be awarded on the following scale: 

Rates = 0% to .25% MHl points 

Rates = 0.26°o to .50°oMHl 5 points 

Rates = .51°o to .75°oMHl 20 points 

Rates = . 76° to 1.0°oMHl 40 points 

Rates = LOTo or greater MHI 50 points 



Authority- G.S. 159G-5: 159G-15. 

.0606 SOURCE PROTECTION AND MANAGEMENT 

The maximum value to be given for source protection and 
management categorical elements is 10 points. Points shall only 
be awarded for existing activities or programs that efficiently 
protect the public health, as follows: 

(1 ) Participation in source water protection activities: 
points may be avsarded in Sub-Items (a) and (b) of 
this Item up to the maximum, as follows: 

(a) Voluntary water supply watershed protection 
activities, five points, or 

(b) Voluntary wellhead protection program, five 
points. 

Efficient v\'ater use, as shown bv tfie applicant's 
establishment and administration of tfie described 
programs: points may be avsarded in Sub-Items (a), 
(b). and (c) of tliis Item u^ to the maximum, as 
follows: 

(a) Water loss reduction program which includes 
water audits, comprehensive metering, and 
hidden leak detection, three points: 
Cross-connection control program, three 
points: 

Demand management strategies, such as a 
water conservation incentive rate structure, 
incentives for new or replacement installation 
of low fioyv faucets, showerheads and toilets. 



01 






or a water reclamation or reuse system. 3 
points. 

Aiithont}- G.S. 159G-5: 159G-15. 

SECTION .0700 - AWARD, COMMITMENT AND 
DISBURSEMENT OF LOANS 



.0701 DETERMINATION OF AWARDS AND 
BYPASS PROCEDURES 

(a) All funds appropriated for a fiscal year and all other funds 
accruing from loan principal repayments, interest payments, 
interest earned on funds, excess funds not awarded in the 
preyious priorin review period, and any other source, will be 
a\ailable for loans during the priority review period. 

(^ Of the funds available at tlie beginning of a priority 
rey leys period, five percent will be set aside for potential 
adjustments under Rule .0703 of this Section. Any funds set 
aside for this purpose that are not used to adjust loans during a 
priorin review period will return to die account for the next 
priority rey iey\ period. 

(c) The funds available in a priority review period will be 
awarded in descending order of priority rating considering 
Section .0201(b) of this Subchapter except for projects that are 
not ready to proceed. A project shall be funded unless at the time 
of binding agreement: 

( 1) Project plans and specifications are not approved by 
the receiving agency: 

(2) Any environmental assessment or impact statement 



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required is not complete and approved; 

(3) One hundred percent funding necessary for the 
project is not committed; or 

(4) The receiving agency is unable to determine from 
review of the business plan and other information 
whether the applicant can meet capacity development 
requirements as required by the Division. 

Authohn' G.S. 159G-5: 159G-15. 



Authority G.S. 159G-5: 159G-15. 

.0705 TERMINATION OF LOANS 

Loan commitments may be terminated by the 



receivmg agency 



when recipients do not meet project schedules, if they fail to 
award contracts within one year, or if they fail to comply with 
applicable federal requirements. 



Authohtv G.S. 159G-5: 159G-15. 



.0702 CERTIFICATION OF ELIGIBILITY 

(a) The receiving agency shall create a certificate of eligibility 
for each applicant for which a loan has been made. 

£bj The certificate of eligibility shall indicate that the 
applicant meets all eligibility criteria and that all other 
requirements of the Act have been met. 

(c) The certificate of eligibility shall also indicate the amount 
and the fiscal year of the loan commitment. 

Authoht\>G.S 159G-5: 159G-15. 



SECTION .0800 - LOAN REPAYMENTS 

.0801 INTEREST RATES 

The interest rate to be charged on loans under this Subchapter 
will be set in each priority review period at the lesser of four 
percent per annum or one half the prevailing national market rate 
as derived from the Bond Buyer's 20-Bond Index in accordance 
with G.S. 159G-4(c). 

Authohtv G.S 159G-5; 159G-15. 



.0703 CRITERIA FOR LOAN ADJUSTMENTS 

Upon receipt of bids, a loan commitment may be adjusted as 
follows: 

The loan commitment may be decreased, provided the 
project cost as bid is less than the estimated project 
cost, and the receiving agency approves the loan 
commitment decrease; 

The loan commitment may be increased a maximum 
of 10 percent by the receiving agency provided: the 
project cost as bid is greater than the estimated project 
cost; the project as bid js in accordance with the 



OJ 



£2] 



.0802 REPAYMENT OF PRINCIPAL AND INTEREST 

(a) The debt instrument setting the terms and conditions of 
repayment of loans under this Subchapter will be established 
after the receipt of bids. Adjustments to the loan may be made 
only under Rule .0703 of this Subchapter. 

(b) The maximum maturity on any construction loan shall not 
exceed 20 years. 

(c) The maximum maturity on any project planning loan shall 
not exceed five years. 

(d) Interest on the debt instrument shall begin to accrue on the 
original date that a project's contracts are scheduled to be 
completed. Extensions of this deadline are not allowed. 



project for which the loan commitment was made; the 

receiving agency has reviewed the bids and (e) All principal payments will be made annually on or before 



determined that substantial cost savings would not be 
available through project revisions without 
jeopardizing the integrity of the project; and adequate 
funds are available in tlie Fund. Increases greater 
than 10 percent of thie loan commitment require 
approval by the Local Government Commission. 

Authority G.S 159G-5; 159G-15. 

.0704 DISBURSEMENT OF LOANS 

(a) Disbursement of loan monies shall be made at intervals as 
work progresses and expenses are incurred. No disbursement 
shall be made until the receiving agency receives satisfactor\' 
documentation of incurred costs. At no time shall disbursement 
exceed the allowable costs which have been incurred at that 
time. 

(b) No disbursement shall be made until the receiving agency 
receives documentation of compliance with the verifiable 
percentage goal for participation by minority businesses in 
accordance with G.S. 143-128(c) and any eligible federal and 
state laws. 

(c) The receiving agency will authorize the Controller's 
Office of the Department of Environment and Natural Resources 
to make loan disbursements. 



May 1 or November 1 . The first principal payment is due not 
earlier than six months after the date of completion of the 
project. 

(f) All interest payments will be made semiannually on or 
before May I and November 1 of each year. The first interest 
payment is due not earlier than six months after the date of 
completion of the project. 

(g) All principal and interest payments shall be made payable 
to the Fund. 

Authority^ G.S 159G-5: 159G-15. 

SECTION .0900 - INSPECTION AND AUDIT OF 
PROJECTS 

.0901 INSPECTION 

Inspection of a project to which a loan has been committed 
may be made by thie receiving agency to determine the 
percentage of completion of the project for disbursements, and 
for compliance with all applicable laws and rules. 

Authority G.S 159G-5: 159G-15. 

.0902 AUDIT 



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PROPOSED RULES 



All projects to which a loan has been committed will be 
audited in accordance with G.S. 159-34 and the United States 
Environmental Protection Office of Water (4606) Drinking 
Water State Revolving Fund Program Guidelines. EPA 816-R- 
97-005 February' (28) 1997 which is incorporated in Rule .0103 
of this Subchapter. 

Authority G.S. 159G-5: 159G-15. 

■k-k-k-k'k-kir-k'k'k'k'k'k-k'k'kit'k'k'k 

Notice is hereby given in accordance with G.S. 150B-21.2 
that the DENR-Environmental Management Commission 
intends to adopt the rules cited as 15 NC.4C 2B .02 4 5 -.025 1, 
and amend the rule cited as 15 NC.4C 2 B .0311. Notice of Rule- 
making Proceedings was published in the Register on June 2. 
1998. 

Proposed Effective Date: .April 1. 1999 

A Public Hearing will be conducted at 6:00 p.m. on September 
1. 1998 at the Guilford Technical Community College. 
Jamestown Campus. Applied Technology Center .Auditorium. 
High Point Road. Jamestown, NC. 

Reason for Proposed Action: The Piedmont Triad Regional 
Water .Authority (PTRW.A) has requested that the Environmental 
Management Commission (EMC) reclassify portions of the Deep 
River which upon impoundment, would become the Randleman 
Reservoir Nutrient response models applied to the proposed 
reservoir predict that because of the Irydrologic character of the 
lake and the nutrient loading expected, the lake could experience 
excessive growths of algae and exceed the state 's chlorophyll a 
standard in some of its segments. Because of these predictions, 
the Division has required that a management strategy be 
developed to assure that the highest level of protection is 
provided for the lake. PTRIVA provided a draft plan in March 
1 998 and the Division has revieiied the plan and utilized much 
of the information provided in deciding what type of strategy is 
appropriate for the lake. The "Watershed Management 
Strategy" proposed by the EMC includes an Option .4 and an 
Option B. In Option B. streams within the proposed Randleman 
Resen'oir water supply watershed are proposed for 
reclassification from Class C to Class WS (Water Supply I-IV 
Nutrient Sensitive Haters (NSW). There is a Class B (primary 
recreation) stream which would be reclassified to WS-IV & B 
NSW. In Option .4. the proposal does not include applying the 
supplemental NSH' classification to these streams. To 
implement a "Watershed Management Strategy", much of the 
controls would need to be implemented through the adoption of 
new rules by the EMC. The proposed new rules would be 
codifiedin 15A NCAC 2B .0245 - .0251. The specific portion of 
the North Carolina Water Supply Watershed Protection .Act that 
the Division believes provides the necessary control authorities 
to adopt the proposed management strategy is the provision that 
the "Commission mcry designate water supply watersheds or 
portions thereof as critical water supply watersheds and impose 
management requirements that are more stringent than the 



minimum statewide water supply watershed management 
requirements (G.S. 143-2 14.5(b))." The Division has concluded 
that a management strategy offering a range of options to go out 
to public hearing would provide the most flexibility for the EMC 
in its final decision on which rules to adopt. Therefore, as 
stated above, these proposed rules include an Option A and 
Option B. Both options ha\'e point and nonpoint source 
management components. The EMC may adopt rules that follow 
parts of either option or adopt variations of the limits in bePA'een 
those proposed by either option. These rules will apply to the 
entire Randleman Reservoir drainage area, from the source of 
the Deep River to the Randleman Reservoir dam, including all 
tributaries. 

OPTION A (ISA NCAC 2B .0245, .0247) l^onpoint Source 
Controls 

1. Local governments without watershed protection 
ordinances shall adopt minimum statewide water supply 
requirements. 

2. Local governments with ordinances more stringent than 
statewide minimums cannot reduce existing provisions. 

3. The PTRW.A shall submit an annual report to the EMC 
documenting progress on nonpoint source control 
elements offered in their March 8, 1998 "Nutrient 
Reduction Strategy' and Implementation Plan. " 

OPTION A (ISA NCAC 2B .0246) Point Source Controls 

1. The City of High Point Easts ide WWTP will meet a 
monthly cn'erage total phosphorus limit of 0.5 mg/l. 

2. The City of High Point Eastside WWTP will also adopt a 
goal to achieve a monthly cn'erage phosphorus limit of 
0.2 mg/l. 

OPTION B (ISA .WCAC 2B .0248, .02 SO, .02SI) Nonpoint 
Source Controls 

1. .All local governments shall adopt or modify watershed 
protection ordinances to require a 50' riparian buffer 
area (30' of forested buffer and 20' of vegetated buffer) 
for all perennial and intermittent streams. 

2. .All local governments shall adopt or modify watershed 
protection ordinances to include the following changes 
and provisions: 

• In the Critical .Areas (area 1/2 mile and draining to 
reservoir), the density to be considered "low density" 
will be no more than one dwelling unit (du) per two 
acres or 6% built upon area. 

• In the remainder of watershed the density to be 
considered "low density" will be no more than I 
dw'acre or 12% built upon area 

• In the Critical .Areas for "high density" development, 
the maximum built-upon area allowed will be 30%. In 
the remainder of the watershed, for "high density" 
development, the maximum built upon area allowed 
will be 50%. 

3. Local governments shall complete a comprehensive land 
use planning effort that includes evaluation of existing 
densities and controls and identifies opportunities for 
reducing built upon areas and their impact on surface 
waters. 

4. Local governments shall provide for the implementation 
of watershed protection public education initiatives. 



368 



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PROPOSED RULES 



5. Local government watershed protection programs shall 
provide for identification and removal of illegal 
discharges. 

6. Local government watershed protection programs are to 
provide for identification of locations for stormwater 
retrofits. 

OPTION B (ISA NCAC 2B .0249) Point Source Controls 

1. Two Options Offered for Point Source Controls: 

* High Point relocate Eastside discharge below dam. or 

• High Point Eastside meet monthly average 
phosphorus concentration limitation of 0.18 mg/l. 

2. No new or expanded discharges in the watershed. 

Comment Procedures: The purpose of this announcement is to 
encourage those interested in this proposal to provide 
comments. You may either attend the public hearing and make 
relevant verbal comments or submit written comments, data or 
other relevant information by October 13, 1998. The Hearing 
Officer may limit the length of time that you may speak at the 
public hearing, ifnecessaiy, so that all those who wish to speak 
may Itave any opportunity to do so. We encourage you to submit 
written comments as well. The EMC is very interested in all 
comments pertaining to the proposed rules. It is veiy important 
that all interested and potentially affected persons or parties 
make their views known to the EMC whether in favor of or 
opposed to any and all provisions of the proposed rules. The 
EMC may not adopt a rule that differs substantially from the text 
of the proposed rule published in the North Carolina Register 
unless the EMC publishes the text of the proposed different rule 
and accepts comments on the new text (see 150B-2 1.2(g)). All 
interested and potentially affected persons are strongly 
encouraged to read the entire announcement and supporting 
information, and make appropriate comments on the proposal. 
Comments should be sent to: Mr Boyd De Vane, NC Division of 
Water Qualit\\ PO Box 29535, Raleigh, North Carolina 27626- 
0535. 

Fiscal Note: These Rules, 15 NCAC 2B .0247, .0250-.0251 
affect the expenditures or revenues of local government funds. 
These Rules, 15 NCAC 2B .0245-.0247, .0249-.0251, .0311 do 
have a substantial economic impact of at least five million 
dollars ($5,000,000) in a 1 2-month period 

CHAPTER 2 - ENVIRONMENTAL MANAGEMENT 

SUBCHAPTER 2B - SURFACE WATER 
AND WETLAND STANDARDS 

SECTION .0200 - CLASSIFICATIONS AND 

WATER QUALITY STANDARDS APPLICATIONS 

TO SURFACE WATERS AND 

WETLANDS OF NORTH CAROLINA 



shall be classified as Water Supply IV (WS-IV) and designated 
by the Environmental Management Commission as a Critical 
Water Supply Watershed pursuant to G.S. 143-2 14.5(b). The 
following rules are to be implemented in al] waters of the 
Randleman Lake water supply watershed: 

(1) Rule .0246 for Wastewater Discharges, and 

(2) Rule .0247 Watershed Protection and Stormwater 
Management. 

(b) Failure to meet requirements of Rules .0246 and .0247 of 
this Section may result in imposition of enforcement measures 
as authorized by G.S. 143-215.6A (civil penalties), G.S. 143- 
215. 6B (criminal penalties), and G.S. 143-215.6C (injunctive 
relief). 

Authority G.S. 143-214.1; 143-214.5; 143.215; 143-215.1; 143- 
215.3(a)(1); 143-215. 6A; 143-215.6B; 143-215.6C. 

.0246 RANDLEMAN LAKE WATER 

SUPPLY WATERSHED: WASTEWATER 
DISCHARGE REQUIREMENTS 

The following is the National Pollutant Discharge Elimination 
System (NPDES) wastewater discharge management strategy for 
the Randleman Lake water supply watershed. The City of High 
Point's Eastside facility shall meet a monthly average total 
phosphorus concentration of 0.5 mg/l year round. It shall be the 
goal for the City of High Point's Eastside facility to meet a 
monthly average total phosphorus concentration of 0.2 mg/l year 
round. 

Authority G.S 143-215; 143-215.1; 143-21 5.3(a)(1). 

.0247 RANDLEMAN LAKE WATER SUPPLY 
WATERSHED: WATERSHED 
PROTECTION AND URBAN 
STORMWATER MANAGEMENT 

(a) Within 270 days of the effective date of this Rule, all local 
governments that have land use authority within the proposed 
Randleman Lake water supply watershed shall adopt local water 
supply ordinances. The ordinances shall at least meet the state's 
minimum guidelines for a WS-IV classification as specified in 
15A NCAC 2B .0104, .0202 and .0216. 

(b) Local governments in the watershed shall not reduce their 
existing ordinance provisions in effect on July 1 , 1 998 which are 
more stringent than minimum state requirements. 

(c) The Piedmont Triad Regional Water Authority (PTRWA) 
will submit an annual report to the Environmental Management 
Commission by January I of each calendar year beginning in the 
year 2000 documenting the status of implementation of 
PTRWA's March 8, 1998 Nutrient Reduction Strategy and 
Implementation Plan, which is hereby incorporated by reference. 

Authority G.S 143-214.1; 143-214.5; 143-2 15.3(a)(1). 



.0245 RANDLEMAN LAKE WATER 

SUPPLY WATERSHED: MANAGEMENT 
STRATEGY 

(a) All waters of the Randleman Lake water supply watershed 



.0248 RANDLEMAN LAKE WATER 

SUPPLY WATERSHED: MANAGEMENT 
STRATEGY 

(a) All waters of the Randleman Lake water supply watershed 
shall be classified as Water Supply IV (WS-IV) and designated 



13:4 



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August 14, 1998 



369 



PROPOSED RULES 



by the Environmental Management Commission as a Critical 
Water SuppK Watershed pursuant to G.S. 143-214. 5(b). The 
following Rules are to be implemented jn a]] waters of the 
Randleman Lake water suppK watershed: 

(1) Rule .0249 for Wastewater Discharges. 

(2) Rule .0250 for Protection and Maintenance of 
Riparian Areas, and 

(3) Rule .0251 for Urban Stormv\ater Management. 

(b) Failure to meet requirements of Rules .0249. .0250 and 
.0251 of this Section ma\ result in imposition of enforcement 
measures as authorized by G.S. 143-215. 6A (civil penalties). 
G.S. 143-215.6B (criminal penalties), and OS, 143-2 15.6C 
(iniuncti\e relief). 

Authority G.S. 143-214.1: 143-214.5: 143-215: 143-215.1: 143- 
215.3laj(l): 143-215.6.4: 143-215.6B: 143-215.6C. 

.0249 RANDLEMAN LAKE WATER SUPPLY 
WATERSHED: WASTEWATER 
DISCHARGE REQUIREMENTS 
POINT SOURCE SUB-OPTION 1 

The following is the National Pollutant Discharge Elimination 
System (NPDES) wastewater discharge management strategy for 
the Randleman Lake water suppK watershed. For purposes of 
this Rule, permitted wastewater discharges means those facilities 
permitted to discharge domestic wastewater or wastewaters 
containing phosphorus: 

( 1 ) There shall be no new or expanding permitted 
wastewater discharges in the watershed. 

(2) The CitN of High Point shall relocate the discharge 
from its Eastside wastewater treatment plant to a point 
located dowTistream of the proposed Randleman Dam 
prior to the proposed Randleman Lake being filled. 
POINT SOURCE SUB-OPTION 2 

The following is the National Pollutant Discharge Elimination 
System (NPDES) wastewater discharge management strategy' for 
the Randleman Lake water suppK watershed. For purposes of 
this Rule, permitted wastewater discharges means those 
facilities permitted to discharge domestic wastewater or 
wastewaters containing phosphorus: 

( 1) The Cin ot" High Point's Eastside facility shall meet 
a monthly a\erage total phosphorus concentration of 
0.18 mg I year round. Compliance y\ith this total 
phosphorus limit shall be required prior to the 
proposed Randleman Lake being filled. If High Point 
pumps its wastewater from the Eastside wastevNater 
treatment plant to a point located below Randleman 
Lake Dam, this total phosphorus limit may be 
modified by the Director through the NPDES permit. 

(2) There shall be no neyv or expanding permitted 
\sastey\ater discharges jn the watershed yvith the 
exception that the City of High Point Eastside 
wastewater treatment plant may be allow ed to expand 
beyond 26 million gallons per day pro\ided that jt 
meets a monthly average total phosphorus 
concentration that would not exceed a permitted total 
phosphorus load of 14.200 pounds per year. 



.Authority- G.S. 143-215: 143-215.1: 143-21 5. 3<a)(l). 

.0250 RANDLEMAN LAKE WATER 

SUPPLY WATERSHED: PROTECTION 
AND MAINTENANCE OF RIPARIAN 
AREAS 

The folloyving is the management strategy for maintaining and 
protecting riparian areas in the Randleman Lake water supply 
watershed: 

( 1 ) Riparian areas shall be protected and maintained in 
accordance yvith this Rule on all sides of surface 
v\ aters in the Randleman Lake yvater supply watershed 
(intermittent streams, perennial streams, lakes, ponds) 
as indicated on the most recent version of United 
States Geological Survey 1:24.000 scale (7.5 minute 
quadrangle) topographic maps, the Soil Survey maps 
developed bv USDA-Natural Resource Conservation 
Service or other site-specific evidence. The Piedmont 
Triad Regional Water Authority (PTRWA) shall 
develop detailed stream network maps for the 
watershed based on these USGS and USDA-NRCS 
maps and field criteria supplied by the Division of 
Water Qualiry. The PTRWA shall submit these maps 
to the Diyision for approval yvith in six months after 
the effective date of this Rule. After these detailed 
stream network maps are approved by the Division, 
riparian areas shall be protected and maintained in 
accordance yvith this Rule on al] sides of surface 
y\ aters in the Randleman Lake water supply yy atershed 
as delineated on these approved stream nenvork maps. 
Exceptions to the requirements of this Rule for 
riparian areas are described in Sub-Items (2)(a)-(h) of 
this Rule. Maintenance of the riparian areas should 
be such that, to tlie maximum extent possible, sheet 
floyy of surface yvater is achieyed. This Rule specifies 
requirements that shall be implemented in riparian 
areas to ensure that the pollutant removal fianctions of 
the riparian area are protected and maintained. All 
local goy emments that hay e land use authority within 
the Randleman Lake water supply yvatershed shall 
adopt and enforce this Rule through local yyater 
supply and other local ordinances. Ordinances shall 
require that ail riparian protection areas are recorded 
on neyv or modified plats. No building permits shall 
be issued and no neyv dey elopment shall take place in 
violation of this Rule. 

(2) The following yvaterbodies and land uses are exempt 
from the riparian area protection requirements: 

(a) Ditches and manmade convey ances. other than 
modified natural streams, yvhich under normal 
conditions do not receive drainage from any 
tributary ditches, canals, or streams, unless the 
ditch or manmade conyevance delivers runoff 
directly to yvaters classified in accordance yvith 
I5ANCAC 2B .0100: 

(b) .Areas mapped as intermittent streams, 
perennial streams, lakes, ponds, or estuaries on 
the most recent versions of United States 



370 



SORTH C.AROLIX4 REGISTER 



August 14, 



1998 



13:4 



«» — — 



PROPOSED RULES 



Geological Survey 1 :24.000 scale (7.5 minute quadrangle) 
topographic maps or soil survey maps where no perennial 
waterbody. intermittent waterbody. lake, pond or estuary actually 
exists on the ground; 

(c) Ponds and lakes created for animal watering, 
irrigation, or other agricultural uses that are not 
part of a natural drainage way that is classified 
in accordance with ISA NCAC 2B .0100; 

(d) Water dependent structures as defined in 15A 
NCAC 2B .0202, provided that they are 
located, designed, constructed and maintained 
to provide maximum nutrient removal, to have 
the least adverse effects on aquatic life and 
habitat and to protect water quality; 

(e) The following uses may be allowed where no 
practical alternative exists. A lack of practical 
alternatives may be shown by demonstrating 
that, considering the potential for a reduction in 
size, configuration or density of the proposed 
activity and all alternative designs, the basic 
project purpose cannot be practically 
accomplished in a manner which would avoid 
or result in less adverse impact to surface 
waters. Also, these structures shall be located, 
designed, constructed, and maintained to have 
minimal disturbance, to provide maximum 
nutrient removal and erosion protection, to 
have the least adverse effects on aquatic life 
and habitat, and to protect water quality to the 
maximum extent practical through the use of 
best management practices. 

£i} Road crossings, railroad crossings, 
bridges, airport facilities, and utility 
crossings may be allowed if conditions 
specified in Sub-Item (2)(e) of this Rule 
are met; 

(ii) Stormwater management facilities and 
ponds, and utility construction and 
maintenance corridors for utilities such 
as water, sewer or gas. ma\ be allowed 
in Zone 2 of the riparian area as long as 
the conditions specified jn Sub-Item 
(2)(e) of this Rule are met and the\ are 
located at least 30 feet from the top of 
bank or mean high water line. 
Additional requirements for utility 
construction and maintenance corridors 
are listed in Sub-Item (2)(f) of this Rule; 

(f) A corridor for the construction and 
maintenance of utility lines, such as water, 
sewer or gas, (including access roads and 
stockpiling of materials) may run parallel to the 
stream and may be located within Zone 2 of the 
riparian area, as long as no practical alternative 
exists, as defmed in Sub-Item (2)(e) of this 
Rule, and best management practices are 
installed to minimize runoff and maximize 
water quality protection to the maximum extent 



practicable. Permanent, maintained access 
corridors shall be restricted to the minimum 
width practicable and shall not exceed 10 feet 
in width except at manhole locations. A 10 
feet by 10 feet perpendicular vehicle 
turnaround is allowed provided they are spaced 
at least 500 feet apart along the riparian area; 
(g) Stream restoration projects, scientific studies, 
stream gauging, water wells, passive recreation 
facilities such as boardwalks, trails, pathways, 
historic preservation and archaeological 
activities are allowed provided that they are 
located in Zone 2 and are at least 30 feet from 
the top of bank or mean high water line and are 
designed, constructed and maintained to 
provide the maximum nutrient removal and 
erosion protection, to have the least adverse 
effects on aquatic life and habitat, and to 
protect water quality to the maximum extent 
practical through the use of best management 
practices. Activities that must cross the stream 
or be located within Zone 1 are allowed as long 
as all other requirements of this Item are met; 
and 
(h) Stream crossings associated with timber 
harvesting are allowed if performed in 
accordance with the Forest Practices 
Guidelines Related to Water Quality (15A 
NCAC IJ .0201-.0209). 
(3) The protected riparian area shall have two zones as 
follows: 

(a) Zone I is intended to be an undisturbed area of 
vegetation. 

(D Location of Zone I: Zone 1 begins at 
the top of bank for intermittent streams 
and perennial streams and extends 
landward a distance of 30 feet on all 
sides of the waterbody. measured 
horizontally on a line perpendicular to 
the waterbody. For all other 

waterbodies. Zone I begins at the top of 
bank or mean high water line and 
extends landward a distance of 30 feet, 
measured horizontally on a line 
perpendicular to the waterbody. 
(ii) The following practices and activities 
are allowed in Zone I : 

(A) Natural regeneration of forest 
vegetation and planting 
vegetation to enhance the 
riparian area jf disturbance is 
minimized, provided that any 
plantings should primarily 
consist of locally native trees and 
shrubs; 

(B) Selective cutting of individual 
trees in Zone 1 as long as the 
following conditions are met 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



371 



PROPOSED RULES 



even, 100 feet on each side of the stream: 

yj Of existing 



inches 



diameter 

(dbh). minimum 



trees 12- 

and greater 
breast height 
of fi\e 



trees must remam uncut: 
(II) Trees 12-inches and 
greater dbh ma\ be 
har\ested based on the 
fo I ] owin geq uat ion : 
Number of Trees 
har\ ested = ( Total number 
of trees greater than 12- 
inches dbh -5) 2: 

(III) No trees less than 12- 
inches dbh can be 
harvested unless 
exceptions provided in 
this Rule are met: 

(IV) Trees ma\ not be 
harvested more frequenth' 
than e\er\ 10 years: and 

(V) No tracked or uheeled 
equipment are allowed. 

(C) Horticulture or sihicultural 
practices to maintain the health 
of individual trees: 

(D) Removal of indi\idual trees 
which are in danger of causing 
damage to dwellings, other 
structures or the stream channel: 

(E) Removal of dead trees and other 
timber cutting techniques 
necessary to prevent extensive 
pest or disease infestation if 
recommended by the Director. 
Division of Forest Resources and 
approved by the Director. 
Division of Water Qualit\: and 

(F) Ongoing agricultural operations 
provided that existing forest 
vegetation is protected. 

The following practices are not allowed 
in Zone 1: 

and 



lA] 



Land-disturbing activities 
placement of fiU and other 
materials, other than those 
in 



allowed 



Items (2) and 



mj 



ID 



(3)(a)(ii) of this Rule, that would 
disturb forest vegetation, as 
defined in Rule .0202 of this 
Section: 

New development, except as 
provided in Sub-Items (2)(d). 
(2>(e) and (2)10 of this Rule: 
New on-site sanitary sewage 
sy stems which use ground 
adsorption: 



(D) The application of fertilizer: and 

(E) Anv activin that threatens the 
health and function of the 
vegetation including, but not 
limited to. application of 
chemicals in amounts exceedi ng 
the manufacturer's recommended 
rate, uncontrolled sediment 
sources on adjacent lands, and 
the creation of any areas with 
bare soil. 

(b) Vegetation in Zone 2 shall consist of a dense 
ground cover composed of herbaceous or 
woody species which provides for diffusion 
and infiltration of runoff and filtering of 
pollutants. 

(iJ Location of Zone 2: Zone 2 begins at 
the outer edge of Zone 1 and extends 
landward a minimum of 20 feet as 
measured horizontally on a line 
perpendicular to tlie waterbody. The 
combined minimum width of Zones 1 
and 2 shall be 50 feet on all sides of the 
waterbodv. 
(ii) The follov\ing practices and activities 
are allowed in Zone 2 in addition to 
those allowed in Zone 1 : 

(A) Periodic mowing and removal of 
plant products such as timber, 
nuts, and fruit is allowed on a 
periodic basis provided the 
intended purpose of tjie riparian 
area is not compromised by 
harvesting, disturbance, or loss 
of forest or herbaceous ground 
cover: and 

(B) Forest v egetation in Zone 2 mav 
be managed to minimize shading 
on adjacent land outside the 
riparian area if the water qualin 
function of tlie riparian area is 
not compromised. 

(iii) The following practices and activities 
are not allowed in Zone 2: 

(A) Land disturbing activities and 
placement of fiU and other 
materials, other than those 
allowed in Items (2) and 
(3)(b)(ii) of this Rule: 

(B) New development, except as 
provided in Sub-Items (2)(e) and 
(2)(f) of this Rule: 

(C) New on-site sanitary sewage 
systems which use ground 
adsorption: 

(D) The application of fertilizer: and 

(E) Any activity that threatens the 
health and function of the 



372 



.\ORTH CAROLISA REGISTER 



Aiwust 14, 1998 



13:4 



PROPOSED RULES 



vegetation including, but not limited to. application of chemicals 
in amounts exceeding the manufacturer's recommended rate, 
uncontrolled sediment sources on adjacent lands, and the 
creation of any areas with bare soil. 



(c) Timber removal and skidding of trees shall be 
directed away from the water course or water 
body. Skidding shall be done jn a manner to 
prevent the creation of ephemera l channels 
perpendicular to the water body. Any tree 
removal must be performed in a manner that 
does not compromise the intended purpose of 
the riparian area and is in accordance with the 
Forest Practices Guidelines Related to Water 
Quality (15ANCAC IJ .0201-.0209). 

(d) Maintenance of sheet flow in Zones 1 and 2 is 
required in accordance with this Item. 

(jj Sheet flow must be maintained to the .0251 



I 



maximum extent practical through 
dispersing concentrated flow and/or re- 
establishment of vegetation to maintain 
the effectiveness of the riparian area. 
£ii} Concentrated runoff from new ditches 
or manmade conveyances must be 
dispersed into sheet flow before the 
runoff enters Zone 2 of the riparian 
area. Existing ditches and manmade 
conveyances, as specified jn Sub-Item 
(2)(a) of this Rule, are exempt from this 
requirement; however, care should be 
taken to minimize pollutant loading 
through these existing ditches and 
manmade conveyances from fertilizer 
application or erosion, 
(iii) Periodic corrective action to restore 
sheet flow should be taken by the 
landowner if necessary to impede the 
formation of erosion gullies which allow 
concentrated flow to bypass treatment in 
the riparian area, 
(e) Periodic maintenance of modified natural 
streams such as canals is allowed provided that 
disturbance is minimized and the structure and 
function of the riparian area js not 
compromised. A grassed travelway is allowed 
on one side of the waterbod\ when alternative 
forms of maintenance access are not practical. 
The width and specifications of the travelway 
shall be only that needed for equipment access 
and operation. The travelway shall be located 
to maximize stream shading. 

(4) Where the standards and management requirements 
for riparian areas are in conflict with other laws, 
regulations, and permits regarding streams, steep 
slopes, erodible soils, wetlands, floodplains. forest 
harvesting, surface mining, land disturbance activities. 
or other environmental protection areas, the more 
protective shall apply. 

(5) Where application of this Rule would prevent all 



reasonable uses of a lot platted and recorded prior to 
the effective date of this Rule, a variance may be 
granted by the Environmental Management 
Commission if it finds that: 

(a) practical difficulties or unnecessary hardships 
would result in strict application of the Rule; 

(b) such difficulties or hardships result from 
conditions which are peculiar to the property 
involved; and 

(c) the general purpose and intent of the Rule 
would be preserved, water quality would be 
protected and substantial justice would be done 
if the variance were granted. 

Authority G.S. 1 43-2] 4. 1: 143-2] 4.5: 143-2] 5.3(a)(1). 



RANDLEMAN LAKE WATER 
SUPPLY WATERSHED: 
STORMWATER REQUIREMENTS 

The following is the urban stormwater management strategy 
for the Randleman Lake water supply watershed: 

(I) All local governments that have land use authority 
within the Randleman Lake water supply watershed 
shall comply with stormwater management 
requirements as outlined in this Rule. 
(2] Within 270 days of the effective date of this Rule, the 
affected jurisdictions, jn coordination with the 
Piedmont Triad Regional Water Authority, shall 
submit local water supply ordinances to the 
Environmental Management Commission for 
approval. The ordinances shall at least meet the 
state's minimum guidelines for a WS-IV classification 
as specified m \SA NCAC 2B .0104. .0202 and 
.0216. except that the following elements in this Rule 
for the Randleman watershed shall replace the 
nonpoint source requirements m 15A NCAC 2B 
.0216(3)(b): 

(a) The local ordinances will provide for review 
and approval of stormwater management plans 
for new developments to ensure that the 
following conditions can be met: 
(i) Stormwater pollution control criteria for 
watershed outside of critical area: 
(A) Low Density Option: For each 
development project- 

development density must be 
limited to either no more than 
one dwelling unit per acre of 
single family detached residential 
development (or 40.000 square 
foot lot excluding roadway right- 
of-way) or 12 percent built-upon 
area for all other residential and 
non-residential development. 
Stormwater runoff shall be 
transported primarily by 
vegetated conveyances. 

Conveyance system shall not 



13:4 



NORTH CAROLINA REGISTER 



PROPOSED RULES 



include a discrete stormwater 
collection system as defined jn 
Rule 15ANCAC 2B .0202. 
(B) High Density Option: If new 
development exceeds the low 
density option requirements as 
stated in Sub-Item (2Ka)(i) of 
this Rule, then engineered 
stormwater controls must be used 
to control runoff from the first 
inch of rainfall. Engineering 
controls may consist of wet 



(Q 



detention ponds designed in 
accordance with 15A NCAC 2H 
■ 1000 or alternative stormwater 



management systems consisting 
of other treatment options, or a 
combination of options, that are 
approved by the Director of the 
Division of Water Quality in 
accordance with 15A NCAC 28 
■0104(g). New residential and 
non residential development shall 
not exceed 50 percent built-upon 
area. 

Cluster development shall be 

allowed on a project-bN -project 

basis as follows: 

(1) overall density of the 

project meets associated 

density or stormwater 

control requirements of 

this Section; 

buffers meet the minimum 



(ID 



(III) 



(IV) 



lY} 



statewide water supply 
watershed protection 
requirements: 
built-upon areas are 
designed and located to 
minimize stormwater 

runoff impact to the 
receiving waters, 

minimize concentrated 
stormwater flow, 

maximize the use of sheet 
flow through vegetated 
areas, and maximize the 
flow length through 
vegetated areas; 
areas of concentrated 
development are located 
in upland areas and awa\'. 
to the maximum extent 
practicable, from surface 
waters and drainagewavs; 
remainder of tract to 
remain in vegetated or 
natural state b\ utilization 



(YD 



of one of the methods 

provided in Sub- Item 

(2¥a)(iVD)(Vn of this 

Rule; 

area jn the vegetated or 

natural state may be 



tym 



lYim 



conveyed to a property 
owners association; a 
local government for 
preservation as a park or 
greenway; a conservation 
organization; or placed in 
a permanent conservation 
or farmland preservation 
easement; 

a maintenance agreement 
for the vegetated or 
natural area shall be Filed 
with the Register of 
Deeds; and 

cluster development that 
meets the applicable low 
density option 

requirements shall 

transport stormwater 

runoff from the 

development by vegetated 



conveyances 
maximum 



to the 
extent 



practicable; 

(D) If local governments choose the 
high density development option 
which requires engineered 
stormwater controls, then they 
shall assume ultimate 
responsibility for operation and 
maintenance of the required 
controls as outlined in Rule 
.0104 of this Subchapter; 

(E) Impervious cover should be 
minimized to the maximum 
extent practical through 
clustering, narrower and shorter 
paved areas (streets, driveways, 
sidewalks, cul-de-sacs, and 
parking lots), spreading rooftop 
and other impervious area runoff 



over pervious areas. 



Land 



clearing during the construction 
process should be limited to the 
maximum extent practical. The 
local government permit shall 
require recorded deed restrictions 
and protective covenants to 
ensure development activities 
maintain the development 
consistent with the plans and 
specifications approved by the 



374 



NORTH CAROLINA REGISTER 



August 1 4, 1998 



13:4 



PROPOSED RULES 



ID 



IGj 



(H} 



local governments; 
The project is in compliance with 
the riparian area protection 
requirements as specified in 1 5 A 
NCAC 2B .0250 (Randleman 
Lake riparian area rule); 
No new development shall be 
allowed within 50 feet of waters 
affected by the Randleman 
riparian area rule 1 5A NCAC 2B 
.0250; 

New development meeting the 
high density option shall be 
located at least 100 feet from 
perennial waters as identified on 
topo or soil survey maps; 
however, within the area between 
50 and 100 feet adjacent to the 
perennial water body, water 
dependent structures, or other 
structures, such as flag poles, 
signs and security lights, which 
result in only diminimus 
increases in impervious area and 
public projects such as road 
crossings and greenways may be 
allowed where no practicable 
alternative exists; these activities 
shall minimize built-upon surface 
area, divert runoff awa\ from 
surface waters and maximize the 
utilization of BMPs; 



(ii) Stormwater pollution control criteria for 
critical areas of the watershed: 

(A) Low Density Option: 
Development density must be 
limited to either no more than 
one dwelling unit per X\\o acres 
of single famih detached 
residential development (or 
80.000 square foot lot excluding 
roadway right-of-way) or six 
percent built-upon area for all 
other residential and non- 
residential development. 
Stormwater runoff shall be 
transported primarily by 
vegetated conveyances to the 
maximum extent practicable. 

(B) High DensitN Option: If new 
development exceeds the low 
density option requirements as 
stated in Sub-Item (2)(a)(ii) of 
this Rule, then engineered 
stormwater controls must be used 
to control runoff from the first 
inch of rainfall. New residential 



and non residential development 



shall not exceed 30 percent built- 
upon area; 

(C) No new permitted sites for land 
application of residuals or 
petroleum contaminated soils 
shall be allowed; 

(D) No new landfills shall be 
allowed; 

£E} Sub-Items (2)(a)(C)-(H) of this 
Rule also apply to the critical 
area. 
(b) Complete a comprehensive stormwater 

management planning effort that includes the 

following elements: 

ti} Evaluation of existing land use within 
Oak Hollow Lake subwatershed. High 
Point Lake subwatershed and Deep 
River I subwatershed in the Randleman 
Lake water supply watershed so that 
overall built-upon area (for existing and 
future development) for each 
subwatershed js minimized and high 
intensity land uses are targeted away 
from surface waters and sensitive areas. 
Oak Hollow Lake subwatershed is 
defined as all land areas draining to Oak 
Hollow Lake. High Point Lake 
subwatershed is defined as all land areas 
draining to High Point Lake. East Fork 
Deep River and West Fork Deep Lake 
from Oak Hollow Lake. Deep River 1 
subwatershed is defined as all land areas 
draining to the Deep River from High 
Point Lake to Freeman Mill Dam; 

(ii) Coordination between all affected 
jurisdictions to encourage their 
development in the existing urban areas. 
Areas of contiguous open space shall be 
protected through conservation 
easements or other long-term protection 
measures. Infrastructure growth shall 
be guided towards existing urban 
development corridors rather than to 
rural lands; and 

(iii) Evaluation of existing ordinances, 
municipal programs (maintenance, street 
cleaning, etc.) and other local policies to 
identify opportunities for stormwater 
quality improvements including 
reducing the amount of built-upon area 
that is required for uses such as parking, 
building setbacks, road widths and cul- 
de-sacs. Consider development options 
such as multiple story buildings, mixed 
use to encourage pedestrian travel and 
mass transit. Identify municipal 
activities and procedures that ma\ be 
modified to allow for stormwater 



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375 



PROPOSED RULES 



m 



til 



tcj 
tdj 
ie) 



pollution prevention opportunities. 
Implementation of watershed protection public 
education programs; 
Identification and removal of illegal 



discharges; and 

Identification of suitable locations for potential 
stormwater retrofits (such as riparian areas) 
that could be funded by various sources. 
Local governments may submit a more stringent local 
stormwater management program plan. Local 
stormwater management programs and modifications 
to these programs shall be kept on file by the Division 
of Water Quality, 

If a local government fails to submit an acceptable 
local stormwater management program plan w ithin the 



time frames established in this 



Rule or fails to 
plan, then 



properly implement an approved 
stormwater management requirements for existing and 
new urban areas within rts jurisdiction will be 
administered through the NPDES municipal 
stormwater permitting program per 15A NCAC 2H 
.0126 which will include at a minimum: 

(a) Subject local governments will be required to 
develop and implement comprehensive 
stormwater management programs for both 
existing and new development. 

(b) These stormwater management programs shall 
provide all components that are required of 
local government stormwater programs in Item 
(2)(a)-(e) of this Rule. 

(c) Local governments that are subject to an 
NPDES permit shall be covered b\' the permit 
for at least one permitting cvcle (five years) 
before they are eligible to submit a revised 
local stormwater management component of 
their \sater supply watershed protection 
program for consideration and approv al b\ the 
EMC. 

Authorities. 143-214.1: 143-214.5: 143-21 5. 3(al(l). 

SECTION .0300 - ASSIGNMENT OF 
STREAM CLASSIFICATIONS 

.0311 CAPE FEAR RIVER BASIN 

(a) Places where the schedules may be inspected: 
(1) Clerk of Court: 
Alamance County 
Bladen County 
Brunswick County 
Caswell County 
Chatham County 
Columbus County- 
Cumberland County 
Duplin County 
Durham County 
Forsyth County 
Guilford Countv 



(2) 



Harnett County 

Hoke County 

Lee County 

Montgomery County 

Moore County 

New Hanover County 

Onslow County 

Orange County 

Pender County 

Randolph County 

Rockingham County 

Sampson County 

Wake County 

Wayne County 

North Carolina Department 

Natural Resources: 

(A) 



I 



of Environment and 



Winston-Salem Regional Office 

8025 North Point Boulevard, Suite 100 

Winston-Salem. North Carolina 

(B) Fayetteville Regional Office 
Wachovia Building 

Suite 714 

Fayetteville. North Carolina 

(C) Raleigh Regional Office 
3800 Barrett Drive 
Raleigh. North Carolina 

(D) Washington Regional Office 
1424 Carolina Avenue 
Washington, North Carolina 

(E) Wilmington Regional Office 
127 Cardinal Drive Extension 
Wilmington, North Carolina 

(b) The Cape Fear River Basin Schedule of Classification and 
Water Quality Standards was amended effective: 

(1) March 1,1977; 

(2) December 13, 1979; 

(3) December 14. 1980; 

(4) August 9. 1981; 

(5) April 1. 1982; 

(6) December 1. 1983; 

(7) January 1. 1985; 

(8) August 1. 1985; 

(9) December 1. 1985; 

(10) February 1. 1986; 

(11) July I. 1987; 

(12) October I. 1987; 

(13) March I. 1988; 

(14) June I. 1988; 

(15) July I. 1988; 

(16) Januan,' 1. 1990; 

(17) August I. 1990; 

(18) August 3. 1992; 

(19) September 1. 1994; 

(20) August 1. 1998; 

(21) Aprill,1999. 

(c) The Schedule of Classifications 



and Water Quality 
Standards for the Cape Fear River Basin has been amended 
effective June 1. 1988 as follows: 



3 -'6 



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(1) Cane Creek [Index No. 16-21-(1)] from source to a 
point 0.5 mile north of N.C. Hwy. 54 (Cane Reservoir 
Dam) including the Cane Creek Reservoir and all 
tributaries has been reclassified from Class WS-llI to 
WS-I. 

(2) Morgan Creek [Index No. 1 6-41 -]-(!)] to the 
University Lake dam including University Lake and 
all tributaries has been reclassified from Class WS-Ill 
toWS-1. 

(d) The Schedule of Classifications and Water Quality 
Standards for the Cape Fear River Basin has been amended 
effective July 1, 1988 by the reclassification of Crane Creek 
(Crains Creek) [Index No. 18-23-16-(l )] from source to mouth 
of Beaver Creek including all tributaries from C to WS-III. 

(e) The Schedule of Classifications and Water Quality 
Standards for the Cape Fear River Basin has been amended 
effective January 1, 1990 as follows: 

(1) Intracoastal Waterway (Index No. 18-87) from 
southern edge of White Oak River Basin to western 
end of Permuda Island (a line from Morris Landing to 
Atlantic Ocean), from the eastern mouth of Old 
Topsail Creek to the southwestern shore of Howe 
Creek and from the southwest mouth of Shinn Creek 
to channel marker No. 153 including all tributaries 
except the King Creek Restricted Area, Hardison 
Creek, Old Topsail Creek, Mill Creek, Futch Creek 
and Pages Creek were reclassified from Class SA to 
Class SA ORW. 

(2) Topsail Sound and Middle Sound ORW Area which 
includes all waters between the Barrier Islands and the 
Intracoastal Waterway located between a line running 
from the western most shore of Mason Inlet to the 
southwestern shore of Howe Creek and a line running 
from the western shore of New Topsail Inlet to the 
eastern mouth of Old Topsail Creek was reclassified 
from Class SA to Class SA ORW. 

(3) Masonboro Sound ORW Area which includes all 
waters between the Barrier Islands and the mainland 
from a line running from the southwest mouth of 
Shinn Creek at the Intracoastal Waterway to the 
southern shore of Masonboro Inlet and a line running 
from the Intracoastal Waterway Channel marker No. 
153 to the southside of the Carolina Beach Inlet was 
reclassified from Class SA to Class SA ORW. 

(f) The Schedule of Classifications and Water Quality 
Standards for the Cape Fear River Basin has been amended 
effective January 1, 1990 as follows: Big Alamance Creek 
[Index No. I6-I9-(I)] from source to Lake Mackintosh Dam 
including all tributaries has been reclassified from Class WS-III 
NSW to Class WS-Il NSW. 

(g) The Schedule of Classifications and Water Quality 
Standards for the Cape Fear River Basin was amended effective 
August 3, 1992 with the reclassification of all water supply 
waters (waters with a primary classification of WS-I, WS-II or 
WS-III). These waters were reclassified to WS-I, WS-II, WS- 
III, WS-IV or WS-V as defined in the revised water supply 
protection rules, (15A NCAC 2B .0100, .0200 and .0300) which 
became effective on August 3, 1992. In some cases, streams 



with primary classifications other than WS were reclassified to 
a WS classification due to their proximity and linkage to water 
supply waters. In other cases, waters were reclassified from a 
WS classification to an alternate appropriate primary 
classification after being identified as downstream of a water 
supply intake or identified as not being used for water supply 
purposes. 

(h) The Schedule of Classifications and Water Quality 
Standards for the Cape Fear River Basin was amended effective 
June I, 1994 as follows: 

(1) The Black River from its source to the Cape Fear 
River [Index Nos. I8-68-(0.5), I8-68-(3.5)and 18-65- 
( 1 1 .5)] was reclassified from Classes C Sw and C Sw 
HQW to Class C Sw ORW. 

(2) The South River from Big Swamp to the Black River 
[Index Nos. 18-68-I2-(0.5) and 18-68-12(11.5)] was 
reclassified from Classes C Sw and C Sw HQW to 
Class C Sw ORW. 

(3) Six Runs Creek from Quewhiffle Swamp to the Black 
River [Index No. 1 8-68-2] was reclassified from Class 
C Sw to Class C Sw ORW. 

(i) The Schedule of Classifications and Water Quality 
Standards for the Cape Fear River Basin was amended effective 
September I, 1994 with the reclassification of the Deep River 
[Index No. 17-(36.5)] from the Town of Gulf-Goldston water 
supply intake to US highway 42 1 including associated tributaries 
from Class C to Classes C, WS-IV and WS-IV CA. 

(j) The Schedule of Classifications and Water Quality 
Standards for the Cape Fear River Basin was amended effective 
August I, 1998 with the reclassification of Deep River and Cape 
Fear WS-IV Protected Areas. The Protected Areas were reduced 
in size. 

(k) The Schedule of Classifications and Water Quality 
Standards for the Cape Fear River Basin was amended 
effective April 1, 1999 with the reclassification of Buckhorn 
Creek (Harris Lake)|Index No. 18-7-(3)| from the 
backwaters of Harris Lake to the Dam at Harris Lake from 
Class C to Class WS-V. 

tlj The Schedule of Classifications and Water Quality 
Standards for the Cape Fear River Basin was amended effective 
April L, 1999 with the reclassification of the Deep River from 
source to the dam at Oakdale-Cotton Mills, Inc., including 
tributaries, from Classes WS-IV and WS-IV CA to WS-IV NSW 
and WS-IV CA NSW. Also, a portion of the Deep River [Index 
No. I7-(4)] from the dam at Oakdale-Cotton Mills, Inc. to the 
dam at Randleman Reservoir (located 1 .6 mile upstream of U.S. 
Hwy 220 Business), and including tributaries, is reclassified 
from Class C and Class B to Class WS-IV NSW and Class WS- 
IV & B NSW. Streams within the Randleman Reservoir Critical 
Area have been reclassified to WS-IV CA NSW. 

Authority G.S. 143-214.1: 143-215.1: 143-21 5.3(a)(1). 

Notice is hereby given in accordance with G.S. 150B-2I.2 
that the Radiation Protection Commission intends to adopt 
the rules cited as 15A NCAC 11 .0359-.0362. .0524-.0525. 



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377 



PROPOSED RULES 



.1653: and amend the rules cited as 15A NCAC 11 .0104. .0111. 
.0117. .0505, .031 ■- .0318, .0321, .0323. .0339. .0353, .0502- 
.0503. .0506-.0513, .0515-.0517. .0520-.0523. .0702-.0703, 
.1003. .1633. .1635, .1647. Notice of Rule-making Proceedings 
was published in the Register on May 15. 1998. 

Proposed Effective Date: .April I. 1999 

A Public Hearing will be conducted at 2:00 p.m. and 7:00 p.m. 
on September 1. 1998 at the Division of Radiation Protection, 
3825 Barrett Drive, Room 101. Raleigh, NC 27609-7221. 

Reason for Proposed Action: The Division of Radiation 
Protection is an agreement state with the US Nuclear 
Regulatory Commission. The Division's rules must be 
compatible with the US Nuclear Regulatory Commission's 
regulations. 

Comment Procedures: Written comments may be submitted to 
Richard M. Fry, Division Director and addressed to: Division 
of Radiation Protection, 3825 Barrett Drive. Raleigh, NC 
27609-~221. Written comments will be accepted until 
September 14, 1998. 

Fiscal Note: This Rule. 15.4 NCAC 11 .0353 affects the 
expenditure or distribution of State finds subject to the 
Executive Budget Act, .Article 1 of Chapter 143. This Rule does 
not have a substantial economic impact of at least five million 
dollars fS5.000.000) in a 1 2-month period. 

Fiscal Note: These Rules. 15 NCAC 11 .0104. .0111. .0117, 
.0305. .03r-.03l8. .0321. .0323. .0339. .0359-.0362, .0502- 
.0503. .0506-.0513. .05 15-. 051'. .0520-.0525, .0702-. 07 03, 
.1003. .1633. . 1635. .164"^.. 1653. do not affect the expenditures 
or revenues of state or local government funds. These Rules do 
not have a substantial economic impact of at least five million 
dollars (55,000.000) in a 12-month period. 

CHAPTER 11 - RADIATION PROTECTION 

SECTION .0100 - GENERAL PROVISIONS 

.0104 DEFINITIONS 

As used in these Rules, the following definitions shall apply. 



(1) 



(2) 



(3) 



(4) 



(5) 
(6) 



"Absorbed dose" means the energ> imparted by 

ionizing radiation per unit mass of irradiated material. 

The units of absorbed dose are the rad and the gray 

(Gy). 

"Accelerator produced material" means an\ material 

made radioactive b\ use of a particle accelerator. 

"Act" means North Carolina Radiation Protection Act 

as defined in G.S. 1 04E- 1 . 

"Activit>" is the rate of disintegration 

(transformation) or decay of radioactive material. The 

units of activit) are the curie (Ci) and the becquerel 

(Bq). 

"Adult" means an individual 1 8 or more \ears of age. 

"Agenc\" means the North Carolina Department of 



Environment and Natural Resources, Division of 
Radiation Protection. 

(7) "Agreement state" means any state with which the 
United States Nuclear Regulatory Commission has 
entered into an effective agreement under Subsection 
274b. of the Atomic Energy Act of 1954, as amended 
(73 Stat. 689). 

(8) "Airborne radioactive material" means any radioactive 
material dispersed in the air in the form of dusts, 
fumes, particulates, mists, vapors, or gases. 

(9) "Airborne radioactivity area" means a room, 
enclosure, or area in which airborne radioactive 
materials, composed wholly or partly of licensed 
radioactive material, exist in concentrations: 

(a) in excess of the derived air concentrations 
(DACs) specified in Appendix B to 10 CFR §§ 
20.1001 -20.2401, or 

(b) to such a degree that an individual present in 
the area without respiratory protective 
equipment could exceed, during the hours an 
individual is present in a week, an intake of 0.6 
percent of the annual limit on intake (ALI) or 
12DAC-hours. 

(10) "ALARA" (acronym for "as low as is reasonably 
achievable") means making every reasonable effort to 
maintain exposures to radiation as far below the dose 
limits in the rules of this Chapter as is practical 
consistent with the purpose for which the licensed or 
registered activity is undertaken, taking into account 
the state of technology, the economics of 
improvements in relation to benefits to the public 
health and safety, and other societal and 
socioeconomic considerations, and in relation to 
utilization of sources of radiation in the public 
interest. 

(11) "Annual limit on intake" (ALI) means the derived 
limit for the amount of radioactive material taken into 
the body of an adult worker by inhalation or ingestion 
in a year. ALI is the smaller value of intake of a given 
radionuclide in a an effective dose equivalent of five 
rems (0.05 Sv) or a committed dose equivalent of 50 
rems (0.5 Sv) to any individual organ or tissue. (ALI 
values for intake by ingestion and by inhalation of 
selected radionuclides are given in Table 1. Columns 
1 and 2. of Appendix Bto 10 CFR §§ 20.1001 - 
20.2401). 

(12) "Annually" means either 

(a) at intervals not to exceed 12 consecutive 
month s , months: or 



378 



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.August 14, 1998 



13:4 



PROPOSED RULES 



(b) 



once per 



at the same time each 






(completed during the same month each 
over a period ot multiple yeai^ 



/ear 

/ear 



(13) "Authorized representative" means an employee of the 
agency, or an individual outside the agency when the 
individual is specifically so designated by the agency 
under Rule .0112 of this Section. 

(14) "Authorized user" means an individual who is 
authorized by license or registration condition to use 
a source of radiation. 

(15) "Background radiation" means radiation from cosmic 
sources: naturally occurring radioactive materials, 
including radon (except as a decay product of source 
or special nuclear material); and global fallout as it 
exists in the environment from the testing of nuclear 
explosive d e vic e s, devices or from past nuclear 
accidents such as Chernobyl that contribute to 
background radiation and are not under the control of 
the licensee or registrant. "Background radiation" 
does not include sources of radiation regulated by the 
agency. 



(16) "Becquerel" is the SI unit of radioactivity. One 
becquerel is equal to one disintegration per second (s" 
'). 

(17) "Bioassay" or "radiobioassay" means the 
determination of kinds, quantities or concentrations, 
and, in some cases, the locations of radioactive 
material in the human body, whether by direct 
measurement (in vivo counting) or by analysis and 
evaluation of materials excreted or removed from the 
human body. 

( 1 8) "Byproduct material" means any radioactive material, 
except special nuclear material, yielded in or made 
radioactive by exposure to the radiation incident to the 
process of producing or utilizing special nuclear 
material. 

(19) "Class", "lung class" or "inhalation class" means a 
classification scheme for inhaled material according 
to its rate of clearance from the pulmonary region of 
the lung. Materials are classified as D, W, or Y, 
which applies to a range of clearance half-times as 
follows: 



CLASSIFICATION OF INHALED MATERIAL 






Class 

Class D (Day) 
Class W (Weeks) 
Class Y (Years) 



Clearance half-time 
less than 1 days 
1 days to 1 00 days 
greater than 1 00 days 



(20) "Collective dose" is the sum of the individual doses (3?4 (28) 
received in a given period of time by a specified 
population from exposure to a specified source of 
radiation. (3^(29) 

(21) "Commission" means the North Carolina Radiation 
Protection Commission. 

(22) "Committed dose equivalent" (H^^.n) means the dose 
equivalent to organs or tissues of reference (T) that 

will be received from an intake of radioactive material (3 ^30) 
by an individual during the 50-year period following 
the intake. 

(23) "Committed effective dose equivalent" (H^^o) is the (^£3JJ 
sum of the products of the weighting factors 
applicable to each of the body organs or tissues that f344 (32) 
are irradiated and the committed dose equivalent to 

these organs or tissues (H^ ,,, =S WyHy,,)). 

(24) "Constraint (dose constraint)" means a value above 
which specified licensee actions are required. 

(25) "Controlled area" means an area, outside of a Q2 M33) 
restricted area but inside the site boundar}. access to 

which can be limited by the licensee or registrant for 
any reason. 

(26) "Critical group" means the group of individuals 
reasonably expected to receive the greatest exposure 
to residual radioactivity for any applicable set of 
circumstances. 

(34){27} "Curie" is the special unit of radioactivity. One curie (-334 (34) 
is equal to 3.7 x 10'" disintegrations per second = 3.7 
X 10'° becquerels = 2.22 x 10'- disintegrations per 
minute. 



"Declared pregnant woman" means a woman who has 
voluntarily informed her employer, in writing, of her 
pregnancy and the estimated date of conception. 
"Decommission" means to remove (as a facility) 
safely from service and reduce residual radioactivity 
to a level that permits release of the property for either 
unrestricted use and termination of the license, license 
or for restricted use and termination of the license. 
"Deep-dose equivalent" (Hj). which applies to 
external whole-body exposure, is the dose equivalent 
at a tissue depth of one cm (1000 mg/cm*). 
"Department" means the North Carolina Department 
of Environment and Natural Resources. 
"Depleted uranium" means the source material 
uranium in which the isotope uranium-235 is less than 
0.711 weight percent of the total uranium present. 
Depleted uranium does not include special nuclear 
material. 

"Derived air concentration" (DAC) means the 
concentration of a given radionuclide in air which, if 
breathed by the reference man for a working year of 
2,000 hours under conditions of light work (inhalation 
rate 1 .2 cubic meters of air per hour), results in an 
intake of ALL DAC values are given in Table I. 
Column 3, of Appendix B to 10 CFR §§ 20.1001 - 
20.2041). 

"Derived air concentration-hour" (DAC-hour) is the 
product of the concentration of radioactive material in 
air (expressed as a fraction or multiple of the derived 
air concentration for each radionuclide) and the time 



13:4 



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379 



PROPOSED RULES 



of exposure to that radionuclide, in hours. A licensee 
may take 2,000 DAC-hours to represent one ALI, 
equivalent to a committed effective dose equivalent of 
five rems (0.05 Sv). 

f^44 (35) "Diagnostic clinical procedures manual" means a 
collection of written procedures governing the use of 
radioactive material that describes each method by 
which the licensee performs diagnostic clinical 
procedures and includes other instructions and 
precautions. Each diagnostic clinical procedure 
including but not limited in content to the 
radiopharmaceutical, dosage and route of 
administration, shall be approved by an authorized 
user prior to inclusion in the manual. The radiation 
safety officer shall ensure that the manual includes the 
approved written procedure for all diagnostic clinical 
procedures performed at the facility. 
(36) "Distinguishable fi^om Background" means that the 
detectable concentration of a radionuclide is 
statistically different from the background 
concentration of that radionuclide in the vicinity of 
the sjte or, in the case of structures, jn similar 
materials using adequate measurement technology, 
survey and statistical techniques. 
"Dose" (or radiation dose) is a generic term that 
means absorbed dose, dose equivalent, effective dose 
equivalent, committed dose equivalent, effective dose 
equivalent, or total effective dose equivalent, as 
defined in other Items of this Rule. 
"Dose equivalent" (Hj) means the product of the 
absorbed dose in tissue, quality factor, and all other 
necessary modifying factors at the location of interest. 
The units of dose equivalent are the rem and sievert 
(Sv). 

"Dose limits" (see "Limits" defined in this Rule). 
"Dosimetry processor" means an individual or an 
organization that processes and evaluates individual 
monitoring equipment in order to determine the 
radiation dose delivered to the equipment. 
"Effective dose equivalent" (H^) is the sum of the 
products of the dose equivalent to the organ or tissue 
(Hj) and the weighting factors (Wj) applicable to each 
of the body organs or tissues that are irradiated (H^ = 
Sw^H-r). 

(40^ (42) "Embryo/fetus" means the developing human 
organism from conception until the time of birth. 

(444 (43) "Entrance or access point" means any location 
through which an individual could gain access to 
radiation areas or to a source of radiation. This 
includes entry or exit portals of sufficient size to 
permit human entry, irrespective of their intended use. 

f434 (44) "Equipment services" means the selling, installation, 
rebuilding, conversion, repair, inspection, testing, 
survey or calibration of equipment which can affect 
compliance with these Rules by a licensee or 
registrant. 

f434 (45) "Exposure" means being exposed to ionizing radiation 
or to radioactive material. 



(^(37} 



B^(38) 



B^(39) 
B^(40) 



mMA\) 



(444(46) 
(4^(47) 

(444(48) 
(474(49) 

(4g4(50) 



H»4(51) 
(^^(52) 



(^44(53) 



f^a4(54) 



(^^(55) 
(M4(56) 



(^#4(57} 



f^^(58) 
(^^(59) 



"Exposure rate" means the exposure per unit of time, 

such as R/min and mR/h. 

"External dose" means that portion of the dose 

equivalent received from radiation sources outside the 

body. 

"Extremity" means hand, elbow, arm, arm below the 

elbow, foot, knee, or leg below the knee. 

"Eye dose equivalent" applies to the external exposure 

of the lens of the eye and is taken as the dose 

equivalent at a tissue depth of 0.3 centimeter (300 

mg/cm"). 

"Generally applicable environmental radiation 

standards" means standards issued by the U.S. 

Environmental Protection Agency (EPA) under the 

authority of the Atomic Energy Act of 1954 (42 

U.S.C. 2D1 1 et seq;), as amended, that impose limits 

on radiation exposures or levels, or concentrations or 

quantities of radioactive material, in the general 

environment outside the boundaries of locations under 

the control of persons possessing or using sources of 

radiation. 

"Gray" (Gy) is the SI unit of absorbed dose. One gray 

is equal to an absorbed dose of one joule/kilogram 

(lOOrads). 

"High radiation area" means an area, accessible to 

individuals, in which radiation levels could result in 

an individual receiving a dose equivalent in excess of 

0.1 rem (1 mSv) in one hour at 30 centimeters from 

the radiation source or from any surface that the 

radiation penefrates. 

"Hospital" means a facility that provides as its 

primary functions diagnostic services and intensive 

medical and nursing care in the treatment of acute 

stages of illness. 

"Human use" means the internal or external 

administration of radiation or radioactive materials to 

human beings. 

"individual" means any human being. 

"Individual monitoring" means: 

(a) the assessment of dose equivalent by the use of 
devices designed to be worn by an individual; 

(b) the assessment of committed effective dose 
equivalent by bioassay (see Bioassay) or by 
determination of the time-weighted air 
concentrations to which an individual has been 
exposed, i.e.. DAC-hours; or 

(c) the assessment of dose equivalent by the use of 
survey data. 

"Individual monitoring devices" or "individual 
monitoring equipment" means devices designed to be 
worn by a single individual for the assessment of dose 
equivalent such as film badges, thermoluminescent 
dosimeters (TLDs). pocket ionization chambers, and 
personal ("lapel") air sampling devices. 
"Inhalation class" (see "Class" defined in this Rule). 
"Inspection" means an official examination or 
observation to determine compliance with rules, 
orders, requirements and conditions of the agency or 



380 



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13:4 



■ ■■■WUI ■■■WHJ»JIJ --'W»J-H-M 



PROPOSED RULES 






the Commission. 

{§S){60} "Internal dose" means that portion of the dose 
equivalent received from radioactive material taken 
into the body. 

^^^ ^61) "License", except where otherwise specified, means 
a license issued pursuant to Section .0300 of this 
Chapter. 

{40X62} "Licensee" means any person who is licensed by the 
agency pursuant to Section .0300 of this Chapter. 

(44 4(63) "Licensing state" means any state designated as such 
by the Conference of Radiation Control Program 
Directors, Inc. Unless the context clearly indicates 
otherwise, use of the term Agreement State in this 
Chapter shall be deemed to include licensing state 
with respect to naturally occurring and accelerator 
produced radioactive material (NARM). 

(43X64) "Limits" or "dose limits" means the permissible upper 
bounds of radiation doses. 

{65X65} "Lost or missing licensed radioactive material" means 
licensed radioactive material whose location is 
unknown, it includes material that has been shipped 
but has not reached its destination and whose location 
cannot be readily traced in the transportation system. 

{44 X66) "Lung class" (see "Class" as defined in this Rule). 

(67) "Medical use" means the intentional internal or 

external administration of radioactive material or the 

radiation therefrom to patients or human research 

subjects under the supervision of an authorized user. 

{4# X68") "Member of the public" means any individual except 
when that individual is receiving an occupational 
dose. 

{44 X69) "Minor" means an individual less than 18 years of 
age. 

{4?4 (70) "Misadministration" means the administration of the 
following: 
(a) a diagnostic radiopharmaceutical dosage: 

(i) involving a dose to the patient that 
exceeds 5 rems effective dose 
equivalent or 50 rems dose equivalent to 
any individual organ; and 

(A) the wrong patient: 

(B) the wrong radiopharmaceutical; 

(C) the wrong route of 
administration; or 

(D) an administered dosage that 
differs significantly from the 
prescribed dosage; or 

(ii) for sodium iodide 1-125 or 1-131 
involving: 

(A) the wrong patient or wrong 
radiopharmaceutical; or 

(B) an administered dosage that 
differs from the prescribed 
dosage by more than 20 percent 
of the prescribed dosage and the 
difference between the 
administered dosage and 
prescribed dosage exceeds 30 



microcunes; 

(b) a therapeutic radiopharmaceutical dosage: 

(i) involving: 

(A) the wrong patient; 

(B) wrong radiopharmaceutical; 

(C) wrongrouteof administration; or 

(D) when the administered dosage 
differs from the prescribed 
dosage by more than 20 percent 
of the prescribed dosage; or 

(ii) when the administered dosage of 
sodium iodide 1-125 or 1-131 differs 
from the prescribed dosage by more 
than 20 percent of the prescribed 
dosage; 

(c) a teletherapy or accelerator radiation dose: 

(i) involving: 

(A) the wrong patient; 

(B) the wrong mode of treatment; or 

(C) wrong treatment site; 

(ii) when the treatment consists of three or 
fewer fractions and the calculated total 
administered dose differs from the total 
prescribed dose by more than 10 percent 
of the total prescribed dose; 

(iii) when the calculated weekly 
administered dose is 30 percent greater 
than the weekly prescribed dose; or 

(iv) when the calculated total administered 
dose differs from the total prescribed 
dose by more than 20 percent of the 
total prescribed dose; 

(d) a brachytherapy radiation dose: 

(i) involving: 

(A) the wrong patient; 

(B) the wrong radioisotope; or 

(C) the wrong treatment site. This 
excludes, for permanent 
implants, seeds that were 
implanted in the correct site but 
migrated outside the treatment 
site; 

(ii) involving a sealed source that is leaking; 

(iii) when, for a temporary implant, one or 
more sealed sources are not removed 
upon completion of the procedure; or 

(iv) when the calculated administered dose 
differs from the prescribed dose by 
more than 20 percent of the prescribed 
dose; or 

(e) a gamma stereotactic radiosurgery radiation 
dose: 

(i) involving the wrong patient or wrong 

treatment site; or 
(ii) when the calculated total administered 

dose differs from the total prescribed 

dose by more than 1 percent of the 

total prescribed dose. 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



381 



PROPOSED RULES 



f6 ^(71 ) "Mobile nuclear medicine service" means the 
transportation and medical use of radioactive material. 

(69) (72) "Monitoring", "radiation monitoring" or "radiation 
protection monitoring" means the measurement of 
radiation levels, concentrations, surface area 
concentrations or quantities of radioactive material 
and the use of the results of these measurements to 
evaluate potential exposures and doses. 

(W)(J3_1 "Natural radioactivit>" means radioactivity' of 
naturalK occurring nuclides. 

f744 (74) "Nonstochastic effect" means health effects, the 
severitN' of which varies with the dose and for which 
a threshold is believed to exist. Radiation-induced 
cataract formation is an example of a nonstochastic 
effect (also called a deterministic effect). 

f754 (75) "NRC" means the United States Nuclear Regulatory 
Commission or its duK authorized representatives. 

f?34 (76) "Occupational dose" means the dose received b> an 
individual in the course of employment in which the 
individual's assigned duties involve exposure to 
radiation or radioactive material from licensed and 
unlicensed sources of radiation, whether in the 
possession of the licensee or registrant or other 
person. Occupational dose does not include dose 
received from background radiation, as a patient from 
medical practices, from exposure to individuals 
administered radioactive material and released in 
accordance with Rule .0358 of this Chapter, from 
voluntar% participation in medical research programs, 
or as a member of the general public. 

f74 4(77) "Particle accelerator" means an\- machine capable of 
accelerating electrons, protons, deuterons. or other 
charged particles. 

P» )(78) "Person" means an\ individual, corporation, 
partnership, firm, association, trust, estate, public or 
private institution, group. agencN, political subdivision 
of this state, any other state or political subdivision or 
agenc> thereof, and an\ legal successor, 
representati\e, agent or agenc\ of these entities. 

f?64 (79) "Personnel monitoring equipment" means devices, 
such as film badges, pocket dosimeters, and 
thermoluminescent dosimeters, designed to be worn 
or carried b\ an individual for the purpose of 
estimating the dose received b\ the individual. 

f7^ (80) "Pharmacist" means an individual licensed b\ this 
state to compound and dispense drugs, prescriptions 
and poisons. 

"Ph\sician" means an indi\ idual currentK licensed to 
practice medicine in this state. 
"Planned special exposure" means an infrequent 
exposure to radiation, separate from and in addition to 
the annual dose limits. 

f80) (83) "Prescribed dosage" means the quantity of 
radiopharmaceutical activity documented in a written 
directive b> an authorized user. 

f&-l- H84) "Prescribed dose" means: 

(a) for teletherap} or accelerator radiation: 
(i) the total dose; and 






(ii) the dose per fraction as documented in 
the written directive; 

(b) for brachslherapy: 

(i) the total source strength and exposure 

time; or 
(ii) the total dose, as documented in the 

written directive; or 

(c) for gamma stereotactic radiosurgery, the total 
dose as documented in the written directive. 

( 8 2) (85) "Public dose" means the dose received by a member 
of the public from exposure to radiation or radioactive 
material released by a licensee or registrant, or to 
another source of radiation within a licensee's or 
registrant's control. It does not include occupational 
dose or doses received from background radiation, as 
a patient from medical practices, from exposure to 
individuals administered radioactive material and 
released in accordance with Rule .0358 of this 
Chapter, or from voluntary participation in medical 
research programs. 

f8^ (86) "QualitN- factor" (Q) means the modifying factor that 
is used to derive dose equivalent from absorbed dose. 
Qualit\ factors are provided in the definition of rem in 
this Rule. 

f8-4- K87) "Quarter" means a period of time equal to one-fourth 
of the Near observed by the licensee or registrant 
(approximately 13 consecutive weeks), providing that 
the beginning of the first quarter in a year coincides 
with the starting date of the year and that no day is 
omitted or duplicated in consecutive quarters. 
(88) "QuarterK" means either: 

(a) at intervals not to exceed 13 weeks; or 

(b) once per 13 weeks at about the same time 
during each 1 3 week period [(completed during 
the same month of the quarter (first month, 
second month or third month)] each quarter 
over a time period of several quarters. 

"Rad" is the special unit of absorbed dose. One rad is 
equal to an absorbed dose of 100 ergs/gram or 0.01 
joule/kilogram (0.01 gray). 

"Radiation" (ionizing radiation), except as otherwise 
defined in Section .1400 of this Chapter, means alpha 
particles, beta particles, gamma rays, x-rays, neutrons, 
high-speed electrons, high-speed protons, and other 
particles capable of producing ions. 

(-8^ (91) "Radiation area" means an area, accessible to 
individuals, in which radiation levels could result in 
an individual receiving a dose equivalent in excess of 
0.005 rem (0.05 mSv) in one hour at 30 centimeters 
from the radiation source or from an\ surface that the 
radiation penetrates. 

f8^92) "Radiation dose" means dose. 

f89 ^93) "Radiation machine" means an\ device capable of 
producing radiation except devices which produce 
radiation onK from radioactive material. 

(904 (94) "Radiation safety officer" means one who has the 
knowledge and responsibility to appK appropriate 
radiation protection rules. 



f8f)(89 
f8#4(90 



.^.v: 



SORTH CAROLINA REGISTER 



August 14, 1998 



13:4 



PROPOSED RULES 



KHIUL JH,illlUfcW.l.lU».kai^ 



{94^(95} "Radioactive material" means any material, solid, 
liquid, or gas, which emits radiation spontaneously. 

{93)(96} "Radioactive waste disposal facility" means any 
low-level radioactive waste disposal facility, as 
defined in G.S. 104E-5(9c), established for the 
purpose of receiving low-level radioactive waste, as 
defined in Rule .1202 of this Chapter, generated by 
another licensee for the purpose of disposal. 

{95^97} "Radioactive waste processing facility" means any 
low-level radioactive waste facility, as defined in G.S. 
104E-5(9b), established for the purpose of receiving 
waste, as defined in this Rule, generated by another 
licensee to be stored, compacted, incinerated or 
treated. 

{94)(98} "Radioactivity" means the disintegration of unstable 

atomic nuclei by emission of radiation. (97 4(101) 

{9^)£99} "Radiobioassay" means bioassay. 
(9#)£i00j "Recordable event" means the administration of the 
following: 

(a) a radiopharmaceutical or radiation from a 
licensed source without a written directive 
where a written directive is required by Sub- 
items 137(a)(i) (145)(a)(i) and 137(b) (0 
(145)(b)-(f) of this Rule: f9& 4(102) 

(b) a radiopharmaceutical or radiation from a 
licensed source where a written directive is 
required by Sub-items 137(a)(i) (145)(a)(i) and (99){103} 
137(b) (f) (145)(b)-(f) of this Rule without 
recording each administeredf+OO)£i04} 
radiopharmaceutical dosage or radiation dose 
in the appropriate record on a daily basis: 

(c) a radiopharmaceutical dosage of greater than (101 ) ( 105) 
30 microcuries of sodium iodide 1-125 and 1- 
131 when: 

(i) the administered dosage differs from the 
prescribed dosage by more than 10 
percent of the prescribed dosage: and 

(ii) the difference between the administered 



dosage and prescribed dose exceeds 1 5 
microcuries; 

(d) a therapeutic dosage of any 
radiopharmaceutical dosage other than sodium 
iodide 1-125 or 1-131 when the administered 
dosage differs from the prescribed dosage by 
more than 10 percent of the prescribed dosage; 

(e) a teletherapy or accelerator radiation dose 
when the calculated weekly administered dose 
is 15 percent greater than the weekly 
prescribed dose; or 

(f) a brachytherapy radiation dose when the 
calculated administered dose differs from the 
prescribed dose by more than 10 percent of the 
prescribed dose. 

"Reference man" means a hypothetical aggregation of 

human physical and physiological characteristics 

arrived at by international consensus as published by 

the International Commission on Radiological 

Protection. These characteristics may be used by 

researchers and public health workers to standardize 

results of experiments and to relate biological insult to 

a common base. 

"Registrant" means any person who is registered with 

the agency as required by provisions of these Rules or 

the Act. 

"Registration" means registration with the agency in 

accordance with these Rules. 

"Regulations of the U.S. Department of 

Transportation" means the regulations in 49 CFR 

Parts 100-189. 

"Rem" is the special unit of any of the quantities 

expressed as dose equivalent. The dose equivalent in 

rems is equal to the absorbed dose in rads multiplied 

by the quality factor (1 rem = 0.01 sievert). As used 

in this Chapter, the quality factors for converting 

absorbed dose to dose equivalent are as follows: 



QUALITY FACTORS AND ABSORBED DOSE EQUIVALENCIES 



TYPE OF RADIATION 



Quality Factor 



Q 



Absorbed 
Dose Equal 
to a Unit 
Dose Equivalent" 



X-, gamma, or beta radiation 

Alpha particles, multiple-charged 
particles, fission fragments 
and heavy particles of unknown 
charge 

Neutrons of unknown energy 

High-energy protons 



20 
10 
10 



1 



0.05 

0.1 

0.1 



"Absorbed dose in rad equal to one rem or the absorbed dose in gray equal to one sievert. 



If it is more convenient to measure the neufron fluence rate than 
to determine the neutron dose equivalent rate in rems per hour or 



sieverts per hour, one rem (0.01 Sv) of neutron radiation of 
unknown energies may, for purposes of the rules of this Chapter, 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



383 



PROPOSED RULES 



be assumed to result from a total fluence of 25 million neutrons 
per square centimeter incident upon the body. 
If sufficient information exists to estimate the approximate 
energy distribution of the neutrons, the licensee or registrant ma\ 



use the fluence rate per unit dose equivalent or the appropriate 
Q value from the following table to convert a measured tissue 
dose in rads to dose equivalent in rems: 



MEAN QUALITY FACTORS. 0. AND FLUENCE PER UNIT DOSE 
EOUIVALENT FOR MONOENERGETIC NEUTRONS 



Neutron 



(thermal) 



Enerev 


(MeV) 


2.5 


X 10 


1 X 


10-' 


1 X 


ID-" 


1 X 


10-^ 


1 X 


10-^ 


1 X 


10-' 


1 X 


10-= 


1 X 


10-' 


5 X 


10' 


1 




2.5 




5 




7 




10 




14 




20 




40 




60 




Ix 


10- 


2x 


10= 


3 X 


10= 


4x 


10= 



Ouality 
Factor' 
iQ} 

2 

2 

2 

~) 

2 

2 

2.5 

7.5 
11 
11 

Q 

8 

7 

6.5 

7.5 

8 

7 

5.5 

4 

3.5 

3.5 

3.5 



Fluence per 


Unit 


Dose Equivalent'' 


(neutrons cm" 


rem') 


980 


xlO' 




980 


v; 10" 




810 


KlO" 




810 


xlO" 




840 


< 10' 




980 


kW 




lOlC 


xlO' 




170 


k\0' 




39 X 


10' 




27 X 


10" 




29 X 


10' 




23 X 


10' 




24 X 


10' 




24 X 


10' 




17x 


10' 




16x 


10' 




14x 


10' 




16x 


10' 




20 x 


10' 




19x 


10' 




16x 


10' 




14x 


10' 





" Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-cm diameter cylinder tissue-equivalent 

phantom. 

'^ Monoenergetic neutrons incident normalK on a 30-cm diameter c\linder tissue-equivalent phantom. 



( 102) ( 106) "Research and development" means: 

(a) theoretical analysis. exploration. or 
experimentation; or 

(b) the extension of in\estigative findings and 
theories of a scientific or technical nature into ( 103) ( 108) 
practical application for experimental and 
demonstration purposes, including the 
experimental production and testing of models. f+Q4-> ( 109) 
devices, equipment, materials, and processes. 

Research and development does not include the 
internal or external administration of radiation or 
radioactive material to human beings. 
( 107) "Residual radioactivin" means radioactivity jn 
structures, materials, soils, groundwater, and other 
media at a site resulting from activities under thef4^f )(l 10) 
licensee's control. This includes radioactiv its from all 
licensed and unlicensed sources used b\ the licensee, 
but excludes background radiation. U also includes (I06) (l 1 1 ) 
radioactive materials rem.aining at the site as a result 



of routine or accidental releases of radioactive 
material at the site and previous burials at the site. 
even if the burials were made in accordance with the 
provisions of Section .1600 of this Chapter. 
"Respirator) protective device" means an apparatus, 
such as a respirator, used to reduce the individual's 
intake of airborne radioactive materials. 
"Restricted area" means an area, access to which is 
controlled by the licensee or registrant for purposes of 
protecting individuals against undue risks from 
exposure to radiation and radioactive materials. 
Restricted area does not include areas used as 
residential quarters, but separate rooms in a residential 
building ma) be set apart as a restricted area. 
"Roentgen" (R) means the special unit of exposure. 
One roentgen equals 2.58 x lO""" coulombs/kilogram of 
air. 

"Sanitan' sewerage" means a system of public sewers 
for carrying off waste water and refuse, but excluding 



3H4 



NORTH CAROL/\A REGISTER 



August 14, 1998 



13:4 



KoB^eK^m 



PROPOSED RULES 



fW7¥112) 



iim 



OQS MWA) 



{imam 



{iimmi 



{nmim 



443)018} 






f+«)lil9j 



(+44)020} 



m (123) 
W (124) 



44 W125) 



sewage treatment facilities, septic tanks, and leach 
fields owned or operated by the licensee. 
"Sealed source" means radioactive material that is 
permanently bonded, fixed or encapsulated so as to 
prevent release and dispersal of the radioactive 
material under the most severe conditions which are 
likely to be encountered in normal use and handling. 
"Semiannually" means either: 

(a) at intervals not to exceed six months; or 

(b) once per six months at about the same time 
during each six month period (completed 
during the sixth month of each six month 
period over multiple six month periods). 

"Shallow-dose equivalent" (HJ, which applies to the 
external exposure of the skin or an extremity, is taken 
as the dose equivalent at a tissue depth of 0.007 
centimeter (7 mg/cm") averaged over an area of one(44-§ ¥121') 
square centimeter. 

"SI unit" means a unit of measure from the 
International System of Units as established by the 
General Conference of Weights and Measures. 
"Sievert" is the SI unit of any of the quantities 
expressed as dose equivalent. The dose equivalent in 
sieverts is equal to the absorbed dose in grays 
multiplied by the quality factor (1 Sv = 100 rems). 
"Site boundary" means that line beyond which the 
land or property is not owned, leased, or otherwise 
controlled by the licensee or registrant. (116) (122) 

"Source material" means: 

(a) uranium or thorium or any combination of 
uranium and thorium in any physical or 
chemical form; or 

(b) ores which contain, by weight, 0.05 percent or 
more of uranium, thorium, or any combination 
thereof Source material does not include 
special nuclear material. 

"Source of radiation" means any radioactive material, 
or any device or equipment emitting or capable of 
producing radiation. 

"Special form radioactive material" means radioactive 
material which satisfies the following conditions: 
(a) It is either a single solid piece or is contained 

in a sealed capsule that can be opened only by 

destroying the capsule: 

175 (gram contained U-235) + 50 (grams U-233) 
350 200 

"State" means the State of North Carolina. 

"Stochastic effects" means health effects that occur 

randomly and for which the probability of the effect 

occurring, rather than its severity, is assumed to be a 

linear function of dose without threshold. Hereditary (420)026} 

effects and cancer incidence are examples of (127) 

stochastic effects. 

"Survey" means an evaluation of the radiological 

conditions and potential hazards incident to the (424)021} 

production, use, transfer, release, disposal, or 

presence of sources of radiation. When appropriate. 



(b) 



(c) 



The piece or capsule has at least one dimension 
not less than five millimeters (0.197 inch); and 
It satisfies the test requirements specified by 
the U.S. Nuclear Regulatory Commission. 
Subpart F of 10 CFR Part 71, and the tests 
prescribed in Rule .0114 of this Section. A 
special form encapsulation designed in 
accordance with the U.S. Nuclear Regulatory 
Commission requirements. Subpart F of 10 
CFR Part 71, in effect on June 30, 1984, and 
constructed prior to July 1, 1985, may continue 
to be used. A special form encapsulation either 
designed or constructed after June 30, 1985, 
must meet requirements of this definition 
applicable at the time of its design or 
construction. 
"Special nuclear material" means: 

(a) plutonium, uranium-233, uranium enriched in 
the isotope 233 or in the isotope 235, and any 
other material that the United States Nuclear 
Regulatory Commission, pursuant to the 
provisions of Section 51 of the Atomic Energy 
Act of 1954 (42 U.S.C. 2D 11 et seq;), 
determines to be special nuclear material, but 
does not include source material; or 

(b) any material artificially enriched by any of the 
foregoing but does not include source material. 

"Special nuclear material in quantities not sufficient 
to form a critical mass" means uranium enriched in 
the isotope uranium-235 in quantities not exceeding 
350 grams of contained uranium-235; uranium-233 in 
quantities not exceeding 200 grams; plutonium in 
quantities not exceeding 200 grams; or any 
combination of uranium-235, uranium enriched in 
uranium-235 and plutonium in accordance with the 
following formula: For each kind of special nuclear 
material, determine the ratio between the quantity of 
that special nuclear material and the quantity specified 
in this Rule for the same kind of special nuclear 
material. The sum of these ratios for all the kinds of 
special nuclear material in combination shall not 
exceed unity. For example, the following quantities 
in combination would not exceed the limitations and 
are within the formula, as follows: 
+ 50 (grams Pu) is < or= 1 
200 

such an evaluation includes a physical survey of the 
location of sources of radiation and measurements or 
calculations of levels of radiation, or concentrations 
or quantities of radioactive material present. 
"These Rules" means Chapter 1 1 of this Title. 
"To the extent practicable" means to the extent 
feasible or capable of being done or carried out with 
reasonable effort. 

"Total effective dose equivalent" (TEDE) means the 
sum of the deep-dose equivalent (for external 
exposures) and the committed effective dose 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



385 



PROPOSED RULES 



f4334 (129) 



<43 ^130) 



(43^)1133} 
f«^)a34i 



f«4)a42J 



equivalent (for internal exposures). 

"Toxic or hazardous constituent of the waste" means 

the nonradioactive content of waste which, 

notvsithstanding the radioactive content, would be 

classified as "hazardous waste" as defined in 15A 

NCAC 13A .0102(a). 

"T\pe A quantit) " means a quantity' of radioactive f4-274 ( 135) 

material, the aggregate radioactivity' of which does not 

exceed A, for special form radioactive material or A^ 

for normal form radioactive material, where A, and A, 

are given in Rule .0113 of this Section or may be 

determined by procedures described in Rule .0113 of 

this Section. All quantities of radioactive material 

greater than a Type A quantity are Type B. (12 8 ) (136) 

"Unit dosage" means a dosage intended for medical 

use in an individual that has been obtained from a (129) (137) 

manufacturer or preparer licensed pursuant to 10 CFR 

32.72 or equivalent agreement state requirements. (130) (138) 

"Unrefined and unprocessed ore" means ore in its 

natural form prior to any processing, such as grinding, (131) (139) 

roasting, beneficiating. or refining. 

"Unrestricted area" means an area, access to which is (132) (140) 

neither limited nor controlled by the licensee or 

registrant. 

"Very high radiation area" means an area, accessible 

to indi\'iduals. in which radiation levels could result in 

an indi\'idual receiving an absorbed dose in excess of 



500 rads (5 grays) in one hour at one meter from a 

radiation source or from any surface that the radiation 

penetrates. At very high doses received at high dose 

rates, units of absorbed dose (e.g., rads and grays) are 

appropriate, rather than units of dose equivalent (e.g.. 

rems and sieverts). 

"Waste" means low-level radioactive waste as defmed 

in G.S. 104E-5(9a) and includes licensed naturally 

occurring and accelerator produced radioactive 

material which is not subject to regulation by the U.S. 

Nuclear Regulatory Commission under the Atomic 

Energy Act of 1954. as amended, except as defined 

differently in Rule .1202 of this Chapter. 

"Waste, Class A" is defined in Rule .1650 of this 

Chapter. 

"Waste, Class B" is defined in Rule .1650 of this 

Chapter. 

"Waste, Class C" is defined in Rule .1650 of this 

Chapter. 

"Week" means seven consecutive days starting on 

Sunday. 

"Weighting factor". Wy. for an organ or tissue (T) is 

the proportion of the risk of stochastic effects 

resulting from irradiation of that organ or tissue to the 

total risk of stochastic effects when the whole body is 

irradiated uniformly. For calculating the effective 

dose equi\alent. the values of Wj are: 



ORGAN DOSE WEIGHTING FACTORS 



Wt 



Organ or 
Tissue 

Gonads 

Breast 

Red bone marrow 

Lung 

Thyroid 

Bone surfaces 

Remainder 

Whole body 

" 0.30 results from 0.06 for each of 5 "remainder" organs (excluding the skin and the lens of the eye) that receive t 

highest doses. 

^ For the purpose of weighting the external whole body dose (for adding it to the internal dose), a single weighting factor. 

Wy = 1 .0. has been specified. Th e us e of oth e r w e ighting factors for e .xt e mal e xposur e will b e approv e d on a case by cas e 



0.25 

0.15 

0.12 

0.12 

0.03 

0.03 

0.30^ 

1.00^ 



basis until such tim e as sp e cific guidanc e is issu e d. 

"Whole body" means, for purposes of external 
exposure, head, trunk (including male gonads), arms 
abo\ e the elbow, or legs above the knee. 
"Worker" means an individual engaged in work under (4^ ^144) 
a license or registration issued by the agency and 
controlled by a licensee or registrant, but does not ( 137) ( 145) 
include the licensee or registrant. 
"Working lexel" (WL) is any combination of short- 
lived radon daughters (for radon-222: polonium-218, 
lead-214. bismuth-214. and polonium-214: and for 
radon-220; polonium-216. lead-212. bismuth-212. and 



polonium-212) in one liter of air that will result in the 

ultimate emission of 1.3 x 10" MeV of potential alpha 

particle energy. 

"Working level month" ( WLM) means an exposure to 

one working level for 170 hours. 

"Written directive" means an order in writing for a 

specific patient, dated and signed by an authorized 

user prior to the administration of a 

radiopharmaceutical or radiation from a licensed 

source, except as specified in Sub-item (e) of this 

definition, containing the following information: 



386 



\ORTH CAROLIXA REGISTER 



August 14, 1998 



13:4 



iiiumii. ji'wjMji.i.-j^T^-aiTi 



PROPOSED RULES 






(a) for the diagnostic administration of a 
radiopharmaceutical: 

(i) if greater than 30 microcuries of sodium 
iodide 1-125 or 1-131, the dosage to be 
administered in accordance with the 
diagnostic clinical procedures manual; 
or 

(ii) if not subject to Sub-item (a)(i) of this 
Item, the type of study to be performed 
in accordance with the diagnostic 
clinical procedures manual; 

(b) for the therapeutic administration of a 
radiopharmaceutical: 

(i) radiopharmaceutical; 
(ii) dosage; and 
(iii) route of administration; 

(c) for teletherapy or accelerator radiation therapy; 

(i) total dose; 

(ii) dose per fraction; 
(iii) freatment site; and 
(iv) overall treatment period; 

(d) for high-dose-rate remote afterloading 
brachytherapy: 

(i) radioisotope; 
(ii) treatment site; and 
(iii) total dose; 

(e) for all other brachytherapy: 

(i) prior to implantation: 

(A) radioisotope; 

(B) number of sources to be 
implanted; and 

(C) source strengths in millicuries; 
and 

(ii) after implantation but prior to 
completion of the procedure: 

(A) radioisotope; 

(B) treatment site; and 

(C) either: 

(1) total source strength and 

exposure time; or 
(11) total dose; 

(f) for gamma stereotactic radiosurgery: 

(i) target coordinates; 

(ii) collimator size; 

(iii) plug pattern; and 

(iv) total dose. 
M )(146) "Year" means the period of time beginning in January 
used to determine compliance with the provisions of 
Section .1600 of this Chapter. The licensee or 
registrant may change the starting date of the year 
used to determine compliance by the licensee or 
registrant provided that the change is made at the 
beginning of the year and that no day is omitted or 
duplicated in consecutive years. 

Authority G.S. 1 04E-7 (a)(2). 



.0111 



COMMUNICATIONS 



(a) Except as provided in Paragraph (b) of this Rule, all 
communications and reports concerning these Rules, and 
applications filed thereunder, shall be mailed to the agency at 
Division of Radiation Protection, RO. Box 276 8 7, 3825 Barrett 
Drive, Raleigh, North Carolina 27611 76 8 7 27609-7221 or 
delivered to the agency at its office located at 3 8 25 Barr e tt 
Driv e . Ral e igh, North Carolina 27609 7221. the same address. 

(b) Except as specifically instructed otherwise by the agency, 
immediate telephone notification and reports required by the 
rules in this Chapter shall be directed to (919) 571-4141 from 
8:00 a.m. to 5:30 p.m. on workdays. 

Authority G.S. 104E-7. 

.0117 INCORPORATION BY REFERENCE 

(a) For the purpose of the rules in this Chapter, the following 
rules, standards and other requirements are hereby incorporated 
by reference including any subsequent amendments and editions: 

( 1 ) Appendix A, Appendix B and R, Appendix G C, and 
Appendix G to 1 CFR Parts 20. 1 00 1 - 20.240 1 ; 

(2) 10 CFR Part 31, 10 CFR Part 32. JO CFR Part 
35.910, 35.920, 35.930, 35.932. 35.934, 35.940, 
35.941, 35.950, 35.960, 35.970, 35.971, 35.972, 10 
CFR Part 36, 10 CFR Part 40 and 10 CFR Part 50; 

(3) 10 CFR Part 61, 10 CFR Part 70, 10 CFR Part 71, 10 
CFR Part 73, 1 CFR Part 1 1 0, 1 CFR Part 1 40 and 
10 CFR Part 150; 

(4) 21 CFR Part 1010. 21 CFR Part 1020 and 21 CFR 
Part 1040; 

(5) 39 CFR Part 14 and 39 CFR Part 15; 

(6) Postal Service Manual (Domestic Mail Manual) 
Section 124.3 [incorporated by reference in 39 CFR 
Section 111.11]; 

(7) 40 CFR Part 261; 

(8) 49 CFR Parts 100-189; 

(9) "Agreement Between the United States Atomic 
Energy Commission and the State of North Carolina 
for Discontinuance of Certain Commission 
Regulatory Authority and Responsibility within the 
State Pursuant to Section 274 of the Atomic Energy 
Act of 1954. as Amended", signed July 21. 1964; 

(10) "Standards and Specifications for Geodetic Control 
Networks (September 1984); 

(11) "Geometric Geodetic Survey Accuracy Standards and 
Specifications for Geodetic Surveys Using GPS 
Relative Positioning Techniques"; 

(12) "Reference Man: Anatomical. Physiological and 
Metabolic Characteristics" (ICRP Publication No. 23) 
of the International Commission on Radiological 
Protection; 

(13) "10 CFR. Chapter 1. Commission Notices, Policy 
Statements, Agreement States, 46 FR 7540"; and 

(14) American National Standard N43.Q 1991 N432-1980 
"Radiological Safety for the Design and Construction 
of Apparatus for Gamma Radiography". 

(b) The rules, standards and other requirements incorporated 
by reference in Paragraph (a) of this Rule are available for 
inspection at the Department of Environment and Natural 



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August 14, 1998 



387 



PROPOSED RULES 



Resources. Division of Radiation Protection at the address listed 
in Rule .0111 of this Section. Except as noted in the 
Subparagraphs of this Paragraph, copies of the rules, standards 
and other requirements incorporated by reference in Paragraph 
(a) of this Rule may be obtained from the Superintendent of 
Documents. U.S. Government Printing Office. Washington, 
D.C. 20402 at a cost as follows: 

(1) Three dollars ($3.00) for the appendixes listed in 
Subparagraph (a)(] ) of this Rule, available from the 
Division of Radiation Protection; 

(2) Twenty-five dollars ($25.00) for the regulations listed 
in Subparagraph (a)(2) of this Rule in a volume 
containing 10 CFR Parts 0-50; 

(3) Eighteen dollars ($18.00) for the regulations listed in 
Subparagraph (a)(3) of this Rule in a volume 
containing 10 CFR Parts 51-199; 

(4) Eighteen dollars ($18.00) for the regulations listed in 
Subparagraph (a)(4) of this Rule in a volume 
containing 21 CFR Parts 800-1299; 

(5) Sixteen dollars ($16.00) for the regulations listed in 
Subparagraph (a)(5) of this Rule in a volume 
containing 39 CFR; 

(6) Thirty-six dollars ($36.00) for the manual listed in 
Subparagraph (a)(6) of this Rule; 

(7) Thirty-one dollars ($3 1 .00) for the regulations listed 
in Subparagraph (a)(7) of this Rule in a volume 
containing 40 CFR Parts 260-299; 

(8) for the regulations listed in Subparagraph (a)(8) of 
this Rule: 

(A) Twenty-three dollars ($23.00) for a volume 
containing 49 CFR Parts 100-177; and 

(B) Seventeen dollars ($17.00) for a volume 
containing 49 CFR Parts 1 78- 1 99. 

(9) One dollar ($1.00) for the agreement in Subparagraph 
(a)(9) of this Rule, available from the Division of 
Radiation Protection; 

(10) Two dollars and eighty-five cents ($2.85) for the 
standards and specifications in Subparagraph (a)(IO) 
of this Rule, available from the National Geodetic 
Information Center, N/CGI74. Rockwall Building, 
Room 24. National Geodetic Surve\. NOAA. 
Rockville. MD 20852; 

(11) Two dollars and eighty-five cents ($2.85) for the 
standards and specifications in Subparagraph (a)(l 1) 
of this Rule, available from the National Geodetic 
Information Center. NCG 1 74, Rockwall Building, 
Room 24. National Geodetic Survey. NOAA, 
Rockville. MD 20852; 

(12) One hundred and five dollars ($105.00) for the ICRP 
Publication No. 23 in Subparagraph (a)(12) of this 
Rule, available from Pergamon Press. Inc.. Maxwell 
House. Fairview Park. Elmsford. NY 10523; 

(13) Two dollars ($2.00) for the document in 
Subparagraph (a)(13) of this Rule, available from the 
Division of Radiation Protection; and 

(14) Thirty-eight dollars plus five dollars shipping and 
handling ($43.00) for the American National Standard 
N 4 3.9 1991 N432-1980 in Subparagraph (a)(14) of 



this Rule, available from the American National 

Standards Institute, Inc., 1430 Broadway, New York, 

New York 10018. telephone number (212) 642-4900. 

(c) Nothing in this incorporation by reference of 10 CFR Part 

61 in Subparagraph (a)(3) of this Rule shall limit or affect the 

continued applicability of G.S. 104E-25(-;:) and (b). 

Authority G.S. 104E-7: 104E-15(a): 150B-21.6. 

SECTION .0300 - LICENSING OF 
RADIOACTIVE MATERIAL 

.0305 EXEMPT ITEM CONTAINING 

OTHER THAN SOURCE MATERIAL 

(a) Authority to transfer possession or control by the 
manufacturer, processor, or producer of an\ equipment, device, 
commodity, or other product containing source, byproduct, or 
special nuclear material whose subsequent possession, use. 
transfer, and disposal b\ all other persons are exempted from the 
rules of this Chapter may be obtained only from the U.S. 
Nuclear Regulatory Commission. Washington. D.C. 20555. 

(b) Certain items containing radioactive material are exempt 
as provided in this Paragraph. 

( 1 ) Except for persons who apply radioactive material to. 
or persons who incorporate radioactive material into 
the following products, any person is exempt from the 
rules of this Chapter to the extent that he receives, 
possesses, uses, transfers, owns, or acquires the 
following products: 

(A) timepieces or hands or dials containing not 
more than the following specified quantities of 
radioactive material and not exceeding the 
following specified levels of radiation: 
(i) 25 millicuries of tritium per timepiece; 
(ii) five millicuries of tritium per hand; 
(iii) 1 5 millicuries of tritium per dial (bezels 
when used shall be considered as part of 
the dial); 
(iv) 100 microcuries of promethium-147 per 
watch or 200 microcuries of 
promethium-147 per an\ other 
timepiece; 
(v) 20 microcuries of promethium-147 per 
watch hand or 40 microcuries of 
promethium-147 per other timepiece 
hand; 
(vi) 60 microcuries of promethium-147 per 
watch dial or 120 microcuries of 
promethium-147 per other timepiece 
dial (bezels when used shall be 
considered as part of the dial); 
(vii) the levels of radiation from hands and 
dials containing promethium-147 will 
not exceed, w hen measured through 50 
milligrams per square centimeter of 
absorber: 

(1) for wrist watches. 0.1 millirad 
per hour at 10 centimeters from 



3HH 



NORTH CAROLINA REGISTER 



Aiisust 14, 1998 



13:4 



PROPOSED RULES 



V»ttML& UfVimi^ii. fvil 



any surface; 
(II) for pocket watches, 0.1 miliirad 
per hour at one centimeter from 
any surface; 
(III) for any other timepiece, 0.2 
miliirad per hour at 10 
centimeters from any surface. 

(B) lock illuminators containing not more than 15 
millicuries of tritium or not more than two 
millicuries of promethium-147 installed in 
automobile locks (the levels of radiation from 
each lock illuminator containing 
promethium-147 shall not exceed one miliirad 
per hour at one centimeter from any surface 
when measured through 50 milligrams per 
square centimeter of absorber); 

(C) balances of precision containing not more than 
one millicurie of tritium per balance or not 
more than 0.5 millicurie of tritium per balance 
part; 

(D) automobile shift quadrants containing not more 
than 25 millicuries of tritium; 

(E) marine compasses containing not more than 
750 millicuries of tritium gas and other marine 
navigational instruments containing not more 
than 250 millicuries of tritium gas; 

(F) thermostat dials and pointers containing not 
more than 25 millicuries of tritium per 
thermostat; 

(G) electron tubes, provided that each tube does not 
contain more than one of the following 
specified quantities of radioactive material: 

(i) 1 50 millicuries of tritium per microwave 
receiver protector tube or 10 millicuries 
of tritium per any other electron tube; 

(ii) one microcurieof cobalt-60; 

(iii) five microcuries of nickel-63; 

(iv) 30 microcuries of krypton-85; 
(v) five microcuries of cesium- 137; 

(vi) 30 microcuries of promethium-147; and 
provided further, that the levels of 
radiation from each electron tube 
containing radioactive material does not 
exceed one miliirad per hour at one 
centimeter from any surface when 
measured through seven milh'grams per 
square centimeter of absorber (for 
purposes of this Subparagraph, "electron 
tubes" include spark gap tubes, power 
tubes, gas tubes including glow lamps, 
receiving tubes, microwave tubes, 
indicator tubes, pickup tubes, radiation 
detection tubes and any other 
completely sealed tube that is designed 
to conduct or control electrical 
currents); 
(H) ionizing radiation measuring instruments 

containing for purposes of internal calibration 



or standardization, sources of radioactive 

material each not exceeding the applicable 

quantity set forth in Rule .0304(e) of this 

Section. 

(1) spark gap irradiation containing not more than 

one microcurie of cobalt-60 per spark gap 

irradiator for use in electrically ignited fuel oil 

burners having a firing rate of at least three 

gallons ( 1 1 .4 liters) per hour. 

(2) For purposes of Part (b)(1)(H) of this Rule, where 

there is involved a combination of radionuclides, the 

limit for the combination shall be derived as follows: 

(A) Determine for each radionuclide in an ionizing 
radiation measuring instrument the ratio 
between the quantity present in the instrument 
and the exempt quantity established in Rule 
.0304(e) of this Section for the specific 
radionuclide when not in combination; 

(B) No ratio shall exceed one and the sum of such 
ratios shall not exceed 10. 

(C) For the purpose of Part (b)(1)(H) 0.05 
microcurie of americium-241 is considered an 
exempt quantity under Rule .0304 of this 
Section. 

(c) Self-luminous products are exempt as provided in this 
Paragraph. 

(1) Except for persons who manufacture, process, or 
produce self-luminous products containing tritium, 
krypton-85, or promethium-147, any person is exempt 
from the rules of this Chapter to the extent that any 
person receives, possesses, uses, fransfers, owns, or 
acquires tritium, krypton-85 or promethium-147 in 
self-luminous products manufactured, processed, 
produced, imported, or transferred in accordance with 
a specific license issued by the U.S. Nuclear 
Regulatory Commission pursuant to Section 32.22 of 
10 CFR Part 32, which license authorizes the transfer 
of the product to persons who are exempt from 
regulator)' requirements. 

(2) The exemption in Subparagraph (c)(1) of this Rule 
does not apply to tritium, krypton-85. or 
promethium-147 used in products for frivolous 
purposes or in toys or adornments. 

(d) Gas and aerosol detectors are exempt as provided in this 
Paragraph. 

(1) Except for persons who manufacture, process, or 
produce gas and aerosol detectors containing 
radioactive material, any person is exempt from the 
rules of this Chapter to the extent that any person 
receives, possesses, uses, transfers, owns or acquires 
radioactive material in gas and aerosol detectors 
designed to protect life or property from fires and 
airborne hazards provided that detectors containing 
radioactive material shall be manufactured, imported, 
or transferred in accordance with a specific license 
issued by the U.S. Nuclear Regulatory Commission or 
any agreement state, pursuant to Section 32.26 of 10 
CFR 32, or equivalent, which authorizes the transfer 



13:4 



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August 14, 1998 



389 



PROPOSED RULES 



of the detectors to persons who are exempt from regulator,' 

requiremems. 

(2) Gas and aerosol detectors previousK manufactured 
and distributed to general licensees in accordance 
with a specific license issued by an agreement state 
shall be considered exempt under Subparagraph (d)( 1 ) 
of this Rule, provided that the devices are labeled in 
accordance with the specific license authorizing 
distribution of the general licensed device, and 
providing further that the devices meet the 
requirements of Rule .0327 of this Section. 

(e) Resins containing scandium-46 are exempt as pro\ ided in 
this Paragraph. 

( 1 ) Any person is exempt from these Rules to the extent 
that such person receives, possesses, uses, transfers, 
owns or acquires synthetic plastic resins containing 
scandium-46 which are designed for sand 
consolidation in oil wells. These resins shall be 
manufactured or imported in accordance \sith a 
specific license issued b> the U.S. Nuclear Regulator) 
Commission, or shall be manufactured in accordance 
with the specifications contained in a specific license 
issued b> the agencv' or anv agreement state to the 
manufacturer of such resins pursuant to licensing 
requirements equivalent to those in Sections 32.16 
and 32.17 of 10 CFR Part 32 of the regulations of the 
U.S. Nuclear Regulator}' Commission. 

(2) This exemption does not authorize the manufacture of 
an\ resins containing scandium-46. 

(f) Capsules containing Carbon- 14 urea for "in-vivo" 
diagnostic use for humans are exempt as provided in this 
Paragraph: 

( 1) Except as provided in Subparagraphs (2) and (3) of 
this Paragraph, any person is exempt from the 
requirements for a license set forth in this Section 
pro\ided that such person recei\es. possesses, uses. 
transfers, ouns or acquires capsules containing 
approximately one microcurie (37kBq) Carbon- 14 
urea each for "in-vi\o_ diagnostic use for humans. 

(2) An\ person who desires to use the capsules for 
research in\oh ing human subjects shall apph for and 
receive a specific license from the agency. 

(3) Any person yvho desires to manufacture, prepare, 
process, produce, package, repackage, or transfer for 
commercial distribution such capsules shall apply for 
and receive a specific license from the U.S. Nuclear 
Regulatory Commission. 

(4) Nothing in this Rule relieves persons from comply ing 
with applicable FDA and other federal regulations, 
and North Carolina requirements governing the 
receipt, administration, and use of drugs. 

Authorises. 104E-~: 104E-10lb): 104E-20. 

.0317 SPECIFIC LICENSES: FILING 
APPLICATION AND GENERAL 
REQUIREMENT 

(a) Applications for specific licenses shall be filed on an 



agency form. Completed applications shall include the 
folloyving information and other information required by the 
agency form; 

( 1 ) name, address and use location of the applicant: 

(2) training and experience of radioactive material users 
and of the person responsible for radiation protection; 

(3) types, quantities and uses of radioactive materials; 

(4) description of facilities, equipment and safety 
program; 

(5) procedures for disposal of radioactive mat e rial. 
material; and 

(6) how facility design and procedures for operation yvill 
minimize, to the extent practical, contamination of the 
facility and the environment, facilitate eventual 
decommissioning, and minimize, to the extent 
practical, the generation of radioactive waste. 

(b) The agency mav' at any time after the filing of the original 
application, and before the expiration of the license, require 
further statements in order to enable the agency' to determine 
whether the application should be granted or denied or whether 
a license should be modified or revoked. 

(c) Each application shall be signed bv' the applicant or 
licensee or a person duly authorized to act on his behalf 

(d) An application for a license may' include a request for a 
license authorizing one or more activities. 

(e) Applications and documents submitted to the agency may' 
be made available for public inspection except as mav' be 
determined otherwise by the agency pursuant to the provisions 
of G.S. 104E-9(4). 

(f) A license application wiW shall be approved if the agency 
determines that: 

(1) the applicant is qualified by' reason of training and 
experience to use the material in question for the 
purpose requested in accordance with these Rules in 
such a manner as to minimize danger to public health 
and safety or property ; 

(2) the applicant's proposed equipment, facilities, and 
procedures are adequate to protect public health from 
radiation hazards and minimize radiological danger to 
life or property'; 

(3) the issuance of the license yvill not be inimical to the 
health and safety of the public; and 

(4) the applicant satisfies any applicable special 
requirements in Rules .0318 to .0336 of this Section. 

(g) As provided by Rule .0353 of this Section, certain 
applications for specific licenses filed under this Section must 
contain a proposed decommissioning funding plan or a 
certification of financial assurance for decommissioning, in the 
case of reneysal applications submitted before the effective date 
of this Rule, this submittal may folloy\ the renewal application 
but must be submitted on or before the effective date of this 
Rule. 

Authority G.S. 104E-": 104E-10(b): 104E-12: 104E-18. 

.0318 SPECIFIC LICENSES: GENERAL 

REQUIREMENTS FOR HUMAN USE 

(a) License required: 



390 



\ORTH C.4ROLI.\4 REGISTER 



August 14. 



1998 



13:4 



■^ 



HBBI 



PROPOSED RULES 



material 
(1) 



(2) 






(1) A person shall not manufacture, produce, acquire, 
receive, possess, use or transfer radioactive material 
for medical use except in accordance with a specific 
license issued by the agency or as allowed pursuant to 
Subparagraphs (a)(2) and (a)(3) of this Rule. 

(2) An individual may receive, possess, use, or transfer 
radioactive material in accordance with the rules of 
this Section under the supervision of an authorized 
user as provided in this Section unless prohibited by 
license condition. 

(3) An individual may prepare unsealed radioactive 
material for medical use in accordance with the rules 
of this Section under the supervision of a pharmacist 
who is an authorized user or physician who is an 
authorized user as provided in this Section unless 
prohibited by license condition. 
A license application for human use of radioactive 

wiH shall be approved if the agency determines that: 
The applicant is qualified by reason of training and 
experience to use the material in question for the 
purpose requested in accordance with these Rules; 
The applicant's proposed equipment, facilities, and 
procedures are adequate to protect public health from 
radiation hazards and minimize radiological danger to 
life or property; 

(3) The issuance of the license will not be inimical to the 
health and safety of the public; 

(4) The following training and supervisory relationship 
are adhered to: 

(A) the user of radioisotopes applied to humans for 
diagnostic, therapeutic, or investigational 
purposes shall be a physician authorized by a 
condition of a specific license, including a 
specific license of broad scope. 

(B) Ne An authorized physician may delegate only 
to persons who are net physicians under the 
supervision of the authorized physician, the 
following: 

(i) the approval of procedures involving the 
administration to patients of 
radiopharmaceuticals or the application 
to patients of radiation from 
radioisotope sources; 

(ii) the prescription of the 

radiopharmaceutical or source of 
radiation and the dose or exposure to be 
administered; 

(iii) the determination of the route of 
administration; 

(iv) the interpretation of the results of 
diagnostic procedures in which 
radiopharmaceuticals are administered; 

(C) The authorized physician shall review the work 
of the supervised individual as it pertains to the 
delegated work in Subparagraph (b)(4) of this 
Rule and the records kept reflecting that work. 

(5) the applicant satisfies any applicable special 
requirements in Rules .03 19 to .0322 of this Section. 



(¥>(c) Subject to the provisions of Subparagraph (a)( 4 ) (b)(4) 
and Paragraphs (e) (d} to (f) (g} of this Rule, an authorized 
physician may permit technicians and other paramedic personnel 
to perform the following activities: 



(1) 



of 



preparation and quality control testing 

radiopharmaceuticals and sources of radiation; 

measurement of radiopharmaceutical doses prior to 

administration; 

use of appropriate instrumentation for the collection 

of data to be used by the physician; 

administration of radiopharmaceuticals and radiation 

from radioisotope sources to patients. 

Authorized physicians who permit activities to be 
performed by technicians and other paramedical personnel 
pursuant to Paragraph (b) (c} of this Rule shall: 



(2) 

(3) 

(4) 

(e)td} 



(1) 



prior to giving permission, determine that the 
technicians and other paramedical personnel have 
been properly trained to perform their duties with 
specific training in the following subjects, as 
applicable to the duties assigned: 



(A) 



of radiation and 



(B) 



(C) 



(D) 



(E) 
(F) 



(2) 



general characteristics 
radioactive materials; 

physical, chemical, and pharmaceutical 
characteristics of each radiopharmaceutical to 
be used; 

mathematics and calculations basic to the use 

and measurement of radioactivity, including 

units of radiation dose and radiation exposure; 

use of radiation instrumentation for 

measurements and monitoring including 

operating procedures, calibration of 

instruments, and limitations of instruments; 

principles and practices of radiation protection; 

additional training in the above subjects, as 

appropriate, when new duties are added. 

assure that the technicians and other paramedical 

personnel receive appropriate retraining in the 

subjects listed in Subparagraph (c)( 1 ) (d)(1) of this 

Rule to maintain proficiency and to keep abreast of 

developments in the field of nuclear medical 

technology; 

keep records showing the bases for the determinations 
of proper training; and 

retain responsibility as licensee or authorized user for 
the satisfactory performance of the activiti e s. 
activites; and 

review the work of the supervised individual and the 
records kept reflecting that work. 
Certification in nuclear medicine technology by the 
American Registry of Radiologic Technologists or in nuclear 
medical technology by the Registry of Medical Technologists of 
the American Society of Clinical Pathologists or the Society of 
Nuclear Medicine w441 shall be deemed to satisfy the training 
requirements in Subparagraphs (c)(1) (d)( 1 ) and (2) of this Rule. 
(e)(D An applicant for a license or for amendment or renewal 
of a license shall state whether he desires to permit technicians 
or other paramedical personnel to perform activities pursuant to 
Paragraph (fe) (cj of this Rule and. if so. shall include in his 



(3) 



(4) 



£5} 



m^ 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



391 



PROPOSED RULES 



application for license, license amendment, or license renewal a 
statement of the activities to be so performed and a description 
of an adequate program for training the personnel, including 
retraining as required to keep abreast of developments in 
technology, or for otherwise determining that the personnel are 
properly trained to perform their duties. 

tf Kg) Whenever a technician or other paramedical person 
administers a radiopharmaceutical to a patient by injection, a 
physician shall be immediately accessible, but not necessarily a 
physician authorized by the agency to be a user of radioisotopes. 

(h) A licensee that permits the preparation of radioactive 
material for medical use by an individual under the supervision 
of an authorized pharmacist as allowed h\ Subparagraph (a)(3) 
of this Rule shall: 



(1) instruct the supervised individual in the preparation of 
radioactive material for medical use and the principles 
of and procedures for radiation safets' and in the 
licensee's written qualit\' management program, as 
appropriate to that individual's use of radioactive 
material; 

(2) require the supervised individual to follow the 
instructions given pursuant to Subparagraph (h)( 1 ) of 
this Rule and to compK with the rules of this Chapter 
and license conditions: and 

(3) require the supervising authorized pharmacist to 
periodicalK review the work of the supervised 
individual as k pertains to preparing radioactive 
material for medical use and the records kept to reflect 
that work. 

(ij A licensee shall appoint a Radiation Safet\ Officer (RSO) 
responsible for implementing the radiation safeK' program. The 
licensee, through the RSO. shall ensure that radiation safety 
activities are being performed m accordance with approved 
procedures and regulatory requirements in the daih' operation of 
the licensee's radioactive material program. 

(i) A licensee shall establish in writing the authoritN: duties 
and responsibilities of the Radiation Safet^ Officer 

(k) A licensee shall provide the Radiation Safet\ Officer 
sufficient authority, organizational freedom, and management 
prerogative to: 

( 1 ) identify radlMi^n safety proWems^ 

(2) investigate radiation safety problems such as 
overexposures, accidents, spills, losses, thefts, 
unauthorized receipts, uses, transfers, disposals, 
misadministrations. and other deviations from 
approved radiation safety practice and implement 
corrective actions as necessar. : 

t3J 



(4J 
ill 



initiate, recommend or provide corrective actions for 

radiation safety problems: 

verify' implementation of c orrective actions; and 

retain records of items listed in Subparagraphs (k)( 1) 

through (4) of this Rule. 
tU For each individual receiving radiopharmaceutical therap\' 
and hospitalized for compliance with Rule .0358 of this Section. 
a licensee shall: 

( 1 ) provide a private room with a private sanitary facility; 

(2) post the individual's door with a "Radioactive 
Materials" sign and note on the door or the 



individual's chart, where and how long visitors may 
stay in the individual's room; 

(3) p romptly, after administration of the dosage, measure 
the dose rates in contiguous restricted and unrestricted 
areas with a radiation measurement survey instrument 
Xp demonstrate compliance with Section .1600 of this 
Chapter; and retain for three years a record of each 
survey that includes the time and date of the survey, a 
plan of tlie area or list of points surveyed, the 
measured dose rate at several points expressed in 
millirem per hour the instrument used to make the 
survey, and the initials of tfie individual who 
performed the survey; 

(4) either monitor material and items removed from the 
individual's room to determine that their radioactivity 
cannot be distinguished from the natural background 
radiation level with a radiation detection survey 
instrument set on its most sensitive sale and with no 
interposed shielding, or handle them as radioactive 
waste; and 

(5) Notify the Radiation Safety Officer and authorized 
user as soon as feasible if the individual has a medical 
emergency and immediately if the patient dies. 

A uthorin- G. S. 1 04 E- '^: 1 04 E- 1 0(b). 

.0321 SPECIFIC LICENSES: GROUPS 
OF DIAGNOSTIC USES 

(a) An application for a specific license pursuant to Rule 
.03 1 8 of this Section for any diagnostic or therapeutic use of 
radioactive material specified in groups established in Paragraph 
(b) of this Rule wil4 shall be approved for all of the diagnostic or 
therapeutic uses within the group which include the use specified 
in the application if: 

( 1 ) the applicant satisfies the requirements in Rule .03 1 9 
of this Section; 

(2) the applicant's proposed radiation detection 
instrumentation is adequate for conducting the 
diagnostic or therapeutic procedure specified in the 
appropriate group; 

(3) the physicians designated in the application as 
individual users, have ad e quat e clinical experience in 
the types of uses included in the group or groups; 
groups incorporated b\ reference in Rule .01 17(a)(2) 
of this Chapter; 

(4) the physicians and all other personnel who will be 
involved in the preparation and use of radioactive 
material have ad e quat e training and experience in the 
handling of radioactive material appropriate to their 
participation in the uses included in the group or 
groups; groups incorporated by reference in Rule 
.01 17(a)(2) of this Chapter; 

(5) the applicant's applicant has detailed radiation safety- 
operating procedures ar e ad e quat e for handling and 
disposal of the radioactive material involved in the 
uses included in the group or groups, groups that 
provide protection to the workers, the public and the 
environment from radiation exposure and radioactive 



392 



NORTH CAROLINA REGISTER 



August 14, 



1998 



13:4 



PROPOSED RULES 



TMB I^ t WBTOC^ST 






contamination. 

(b) The groups of diagnostic and therapeutic 
radiopharmaceutical uses are established as follows: 

(1) Group I includes radiopharmaceuticals for which a 
New Drug application has been approved by the U.S. 
Food and Drug Administration for diagnostic studies 
involving measurement of uptake, dilution and 
excretion. This group does not include the use of any 
radiopharmaceutical disapproved by the North 
Carolina Radiation Protection Commission or 
involving imaging, tumor localization or therapy. 

(2) Group II includes radiopharmaceuticals for which a 
New Drug application has been approved by the U.S. 
Food and Drug Administration for diagnostic studies 
involving imaging and tumor localizations. This 
group does not include the use of any 
radiopharmaceutical disapproved by the North 
Carolina Radiation Protection Commission. 

(3) Group III includes the use of generators and reagent 
kits for which a New Drug application has been 
approved by the U.S. Food and Drug Administration 
for the preparation of radiopharmaceuticals for certain 
diagnostic uses. This group does not include any 
generator or reagent kit disapproved by the North 
Carolina Radiation Protection Commission. 

(4) Group IV includes radiopharmaceuticals for which a 
New Drug application has been approved by the U.S. 
Food and Drug Administration for therapeutic uses 
which do not normally require hospitalization for 
purposes of radiation safety. This group does not 
include any radiopharmaceutical disapproved by the 
North Carolina Radiation Protection Commission. 

(c) Any licensee who is authorized to use radioactive material 
in one or more groups pursuant to Paragraph (a) of this Rule is 
subject to the following conditions: 

(1) For Groups I, II and IV, no licensee shall receive, 
possess, or use radioactive materials except as a 
radiopharmaceutical manufactured in the form to be 
administered to the patient, labeled, packaged, and 
distributed in accordance with: 

(A) a specific license issued by the U.S. Nuclear 
Regulatory Commission, pursuant to Section 
32.72 of 10 CFR Part 32; or 

(B) a specific license issued by the agency or an 
agreement state pursuant to equivalent 
regulations. 

(2) For Group III, no licensee shall receive, possess, or 
use generators or reagent kits containing radioactive 
material or shall use reagent kits that do not contain 
radioactive material to prepare radiopharmaceuticals 
containing radioactive material, except: 

(A) reagent kits, not containing radioactive 
material, that are approved by the U.S. Nuclear 
Regulatory Commission, the U.S. Atomic 
Energy Commission, or an agreement state for 
use by persons licensed for Group 111 pursuant 
to Paragraph (a) of this Rule or equivalent 
regulations of an agreement state or the U.S. 



Nuclear Regulatory Commission; 

(B) generators or reagent kits containing 
radioactive material that are manufactured, 
labeled, packaged, and distributed in 
accordance with a specific license issued by the 
U.S. Nuclear Regulatory Commission pursuant 
to S e ction 32.73 of 10 CFR Part 32 or by the 
agency or an agreement state pursuant to 
equivalent regulations; 

(C) any licensee who uses generators or reagent 
kits shall elute the generator or process 
radioactive material with the reagent kit in 
accordance with instructions which are 
approved by the U.S. Nuclear Regulatory 
Commission or an agreement state and are 
furnished by the manufacturer on the label 
attached to or in the leaflet or brochure that 
accompanies the generator or reagent kit. 

(3) For Groups I, II and III, any licensee using radioactive 
material for clinical procedures other than those 
specified in the product labeling package insert shall 
comply with the product labeling regarding: 

(A) chemical and physical form; 

(B) route of administration; and 

(C) dosage range. 

(4) Any licensee who is licensed pursuant to Paragraph 
(a) of this Rule for one or more of the medical use 
groups also is authorized to use radioactive material 
under the general license in Rule .03 14 of this Section 
for the specified IN VITRO uses without filing 
agency form as required by Rule .0314(b) of this 
Section, provided that the licensee is subject to the 
other provisions of Rule .0314 of this Section. 

(5) Any licensee who is licensed pursuant to Paragraph 
(a) of this Rule for one or more of the medical use 
groups in Paragraph (a) of this Rule also is 
authorized, subject to the provisions of Parts (c)(5)(E) 
and (F) of this Rule, to receive, possess, and use for 
calibration and reference standards: 

(A) Any radioactive material listed in Group I, 
Group II, or Group 111 of this Rule with a 
half-life not longer than 100 days, in amounts 
not to exceed 15 millicuries total; 

(B) Any radioactive material listed in Group I, 
Group 11, or Group III of this Rule with 
half-life greater than 100 days in individual 
amounts not to exceed 200 microcuries total; 

(C) Technetium-99m in individual amounts not to 
exceed 30 50 millicuries; 

(D) Any radioactive material in amounts not to 
exceed three 15 millicuries per source 
contained in calibration or reference sources 
that have been manufactured, labeled, 
packaged, and distributed in accordance with: 

(i) a specific license issued to the 
manufacturer by an agreement state 
pursuant to equivalent state regulations; 

(ii) a specific license issued by the U.S. 



13:4 



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August 14, 1998 



393 



PROPOSED RULES 



Nuclear Regulaton Commission 
pursuant to Section 32.74 of 10 CFR, 
Part 32; or 

(iii) an application filed with the U.S. 
Atomic Energy Commission pursuant to 
Section 32.74 of 10 CFR. part 32: or 

(iv) an application filed with an agreement 
state pursuant to equivalent state 
regulations on or before October 15, 
1974 for a license to manufacture a 
source that the applicant distributed 
commercially on or before August 16, 
1974. on which application the U.S. 
Atomic Energy Commission or the U.S. 
Nuclear Regulatory Commission or the 
agreement state has not acted. 

(E) Any licensee who possesses sealed sources as 
calibration or reference sources pursuant to 
Subparagraph (c)(5) of this Rule shall cause 
each sealed source containing radioactive 
materia! other than hydrogen-3 with a half-life 
greater than 30 days in an> form other than gas 
to be tested for leakage or contamination at 
intervals not to exceed six months. In the 
absence of a certificate from a transferor 
indicating that a test has been made within six 
months prior to the transfer, the sealed source 
shall not be used until tested. No leak tests are 
required when: 

(i) The source contains 100 microcuries or 
less of beta or gamma emitting material 
or ten microcuries or less of alpha 
emitting material. 

(ii) The sealed source is stored and is not 
being used. 

Such source shall be tested for leakage 
prior to an> use or transfer unless they 
have been leak tested w ithin six months 
prior to the date of use or transfer. 

(F) The leak test shall be capable of detecting the 
presence of 0.005 microcuries of radioactive 
material on the test sample. The test sample 
shall be taken from the sealed source or from 
the surfaces of the device in which the sealed 
source is permanently mounted or stored on 
which contamination might be expected to 
accumulate. Records of leak test results shall 
be kept in units of microcuries and maintained 
for inspection by the agency. 

(G) If the leak test reveals the presence of 0.005 
microcuries or more of remo\able 
contamination, the licensee shall immediately 
withdra\\ the sealed source from use and shall 
cause it to be decontaminated and repaired or 
to be disposed of in accordance \\ ith ag e nc\ 
Commission rules. A report shall be filed 
\\ ithin five da\s of the test with the agency 
address in Rule .0111 of this Chapter 



describing the equipment involved, the test 
results, and the corrective action taken. 
(H) Any licensee who possesses and uses 
calibration and reference sources pursuant to 
Subparagraph (c)(5) of this Rule shall: 
(i) follow the radiation safety and handling 
instructions approv e d by th e ag e ncy or 
an agr ee m e nt stat e and that are required 
by the licensing agency to be furnished 
by the manufacturer on the label 
attached to the source or permanent 
container thereof or in the leaflet or 
brochure that accompanies the source: 
(ii) maintain such instructions in a legible 

and conveniently available form: 
(iii) conduct a quarterly physical inventory 
to account for all sources received and 
possessed: Records of the inventories 
shall be maintained for inspection by the 
agency and shall include the quantities 
and kinds of radioactive material, 
location of sources and the date of the 
inventory, 
(d) Current lists of the radiopharmaceuticals, generators, 
reagent kits, and associated uses in Group 1 to IV are available 
from the agenc\ at the address in Rule .0111 of this Chapter. 

Authority G.S. 104E-7: 104E- 10(b). 

.0323 SPECIFIC LICENSES: SEALED 
SOURCES IN INDUSTRIAL 
RADIOGRAPHY 

In addition to the requirements set forth in Rule .03 1 7 of this 
Section, a specific license for use of sealed sources in industrial 
radiograph) vhW shall be issued if: 

( 1 ) The applicant has an ad e quat e a program for training 
radiographers and radiographers' assistants to meet the 
requirements of this Rule and Rule .0510 of this 
Chapter and submits to the agencN a schedule or 
description of such program which specifies the: 

(a) initial training: 

(b) periodic training: 

(c) on-the-job training: 

(d) means to be used by the licensee to determine 
the radiographer's knowledge and 
understanding of and ability to comply with 
agency regulations and licensing requirements, 
and the operating and emergencN procedures of 
the applicant: and 

(e) means to be used h\ the licensee to determine 
the radiographer's assistant's knowledge and 
understanding of and ability to compK with the 
operating and emergencv procedures of the 
applicant: 

(2) The applicant has established and submits to the 
agencN satisfacton written operating and emergency 
procedures described in Rule .0513 of this Chapter: 

(3) The applicant has established and submits to the 



.^94 



\ORTH CAROLINA REGISTER 



Ausiist 14, 1998 



13:4 



WW.UI. jii nn»ji^. i^'t.-isra 



9SS«B 



PROPOSED RULES 



agency a description of its inspection program which is adequate 
to ensure that each radiograph e r s radiographer and 
radiograph e r s ' radiographer assistants assistant follow follows 
the rules in this Chapter and the applicant's operating and 
emergency procedur e s, and which must includ e : procedures. 

(a) — obs e r\'ation — of th e — p e rformanc e — of e ach 



perform the test; and 
{#){7} The licensee conducts a program for inspection and 
maintenance of radiographic exposure devices and 
storage containers to assure proper functioning of 
components important to safety. 



radiograph e r — asd — radiograph e r's — assistant Authority G.S. 104E-7; ] 04 E- 10(b). 



(4} 



ms} 



(^)£6} 



during an actual radiographic op e ration at th e 
int e rvals not to e xc ee d thr ee months: provid e d 
that, if a radiograph e r or a radiograph e r's 
assistant has not participat e d in a radiographic 
op e ration for mor e than thr ee months sinc e th e 
last insp e ction, that individual' s p e rformanc e 
must b e obs e rv e d and r e cord e d th e n e xt tim e 
th e individual participates in a radiographic 
operation: and 

(b) — the ret e ntion of insp e ction records on the 
performanc e of radiograph e rs or radiograph e rs' 
assistants for thr ee y e ars; 

The inspection program described in the applicant's 

procedures shall include: 

(a) observation of the performance of each 
radiographer and radiographer's assistant 
during an actual industrial radiographic 
operation at the intervals not to exceed six 
months; provided that, if a radiographer or a 
radiographer's assistant has not participated in 
a radiographic operation for more than six 
months since the last inspection, that 
individual's performance must be observed and 
recorded by a practical examination before the 
individual participates in a radiographic 
operation; 

(b) in those operations where a single individual 
serves as both radiographer and Radiation 
Safety Officer, and performs aM radiography 
operations, an inspection program is not 
required; and 

(c) the retention of inspection records on the 
performance of radiographers or radiographers' 
assistants for three years; 

The applicant submits to the agency a description of 
his overall organizational structure pertaining to the 
industrial radiography program, including specified 
delegations of authority and responsibilit> for 
operation of the program; 

The applicant who desires to conduct his own leak 
tests has established ad e quat e procedures to be 
followed in leak testing sealed sources for possible 
leakage and contamination sufficient to detect 0.005 
microcuries of removable contamination on the 
source, and submits to the agency a description of the 
procedures, including: 



(a) 
(b) 



(0 



instrumentation to be used; 

method of performing tests, e.g.. points on 

equipment to be tested and method of taking 

tests; and 

pertinent experience of the person who will 



.0339 EXPIRATION AND TERMINATION 

OF LICENSES & DECOMMISSIONING 

(a) Each specific license expires at the end of the day on the 
expiration date stated in the license unless the licensee has filed 
an application for renewal, as required in Rule .0340 of this 
Section, not less than 30 days before the expiration date stated 
in the existing license. If an application for renewal has been 
filed at least 30 days prior to the expiration date stated in the 
existing license, the existing license expires at the end of the day 
on which the agency makes a final determination to deny the 
renewal application or. if the determination states an expiration 
date, the expiration date stated in the determination. 

(b) Each specific license revoked by the agency, as provided 
for in Rule .0344 of this Section, expires at the end of the day on 
the date of the agency's final determination to revoke the license, 
or on the expiration date stated in the determination, or as 
otherwise provided by agency order. 

(c) Each specific license continues in effect, beyond the 
expiration date if necessary, with respect to possession of 
residual radioactive material present as contamination until the 
agency notifies the licensee in writing that the license is 
terminated. During this time, the licensee shall: 

(1) limit actions involving radioactive material to those 
related to decommissioning; and 

(2) continue to control entry to restricted areas until they 
are suitable for release for unrestricted use and the 
agency notifies the licensee in writing that the license 
is terminated. 

(d) Within 60 days of the occurrence of any of the following, 
each licensee shall provide notification to the agency in writing 
of such occurrence, and either begin decommissioning its site, or 
any separate building or outdoor area that contains residual 
radioactivity so that the building or outdoor area is suitable for 
release in accordance with Commission requirements, or submit 
within 12 months of notification a decommissioning plan, if 
required by Subparagraph (g)(1) of this Rule, and begin 
decommissioning upon approval of that plan if 

( 1 ) The license has expired pursuant to Paragraphs (a) or 
(b) of this Rule; 

(2) The licensee has decided to permanently cease 
principal activities at the entire site or in any separate 
building or outdoor area that contains residual 
radioactivity such that the building or outdoor area is 
unsuitable for release in accordance with Commission 
requirements; 

(3) No principal activities under the license have been 
conducted for a period of 24 months; or 

(4) No principal activities have been conducted for a 
period of 24 months in any separate building or 
outdoor area that contains residual radioactivity such 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



395 



PROPOSED RULES 



that the building or outdoor area is unsuitable for release in 
accordance with Commission requirements. 

(e) Coincident with the notification requirements set forth in 
Paragraph (d) of this Rule, the licensee shall maintain in effect 
all decommissioning financial assurances established b\ the 
licensee pursuant to Rule .0353 of this Section in conjunction 
v\ ith a license issuance or renewal, or as required b\ this Rule. 
The amount of the financial assurance must be increased, or ma> 
be decreased, as appropriate, to co\er the detailed cost estimate 
for decommissioning established in Paragraph (g) of this Rule. 

(1) An\ licensee who has not provided financial 
assurance to cover the detailed cost estimate 
submitted u ith the decommissioning plan shall do so 
when this Rule becomes effective. 

(2) Following agenc\ approval of the decommissioning 
plan, a licensee ma\ reduce the amount of the 
financial assurance as decommissioning proceeds and 
radiological contamination is reduced at the site \s ith 
the approval of the agenc\. 

(f) The agenc\ ma\ grant a request to extend the time periods 
required in Paragraph (d) of this Rule if the agenc\ determines 
that this relief is not detrimental to the public health and safet> 
and is otherNsise in the public interest. The request shall be 
submitted to the agency no later than 30 da>s before notification 
pursuant to Paragraph (d) of this Rule. The schedule for 
decommissioning set forth in Paragraph (d) of this Rule ma\ not 
commence until the agenc\ has made a determination on the 
licensee's request. 

(g) A decommissioning plan shall be submitted if required b\ 
license condition or if the procedures and acti\ ities necessar> to 
carr> out decommissioning of the site or separate building or 
outdoor area ha\e not been pre\iousK appro\ed b\ the agenc\ 
and these procedures could increase potential health and safety 
impacts to workers or to the public, such as in an\ of following 
cases: 

(1) Procedures would in\ol\e techniques not applied 
routinely during cleanup or maintenance operations; 

(2) Workers would be entering areas not normalK 
occupied where surface contamination and radiation 
ie\els are significantK higher than routineh 
encountered during operation; 

(3) Procedures could result in significantK greater 
airborne concentrations of radioacti\e materials than 
are present during operation; or 

(4) Procedures could result in signitlcantK greater 
releases of radioactive material to the environment 
than those associated with operation. For the purpose 
of Subparagraphs (g)(2)-(4) of this Rule. significantK" 
higher or significantK greater is defined as an 
in crease likeK to result m either an increase in 
radiation exposure to workers or the public in excess 
of one percent of their respective annual radiation 
exposure limit. 

(h) The agency ma\ appro\e an alternate schedule for 
submittal of a decommissioning plan required pursuant to 
Paragraph (d) of this Rule if the agencv determines that the 
altemati\e schedule is necessary to the efTecti\e conduct of 
decommissioning operations and presents no undue risk from 



radiation to the public health and safety and is otherwise in the 
public interest. 

(i) Procedures such as those listed in Paragraph (g) of this 
Rule w ith potential health and safety impacts may not be carried 
out prior to agency approval of the decommissioning plan. 

(j) The proposed decommissioning plan for the site or 
separate building or outdoor area must shall include: 

( 1 ) A description of the conditions of the site or separate 
building or outdoor area sufficient to evaluate the 
acceptability of the plan; 

(2) A description of planned decommissioning activities; 

(3) A description of methods used to ensure protection of 
workers and the environment against radiation 
hazards during decommissioning; 

(4) A description of the planned final radiation survey; 

(5) An updated detailed cost estimate for 
decommissioning, comparison of that estimate with 
present funds set aside for decommissioning, and a 
plan for assuring the availability of adequate funds for 
completion of decommissioning; and 

(6) For decommissioning plans calling for completion of 
decommissioning later than 24 months after plan 
approval, the plan shall include a justification for the 
dela\ based on the criteria in Paragraph (m) of this 
Rule. 

(k) The proposed decommissioning plan wiH shall be 
approved b\ the agenc\ if the information therein demonstrates 
that the decommissioning will be completed as soon as 
practicable and that the health and safety of workers and the 
public will be ad e quat e ly protected. 

(1) Except as provided in Paragraph (m) of this Rule, 
licensees shall complete decommissioning of the site or separate 
building or outdoor area as soon as practicable but no later than 
24 months following the initiation of decommissioning. Except 
as provided in Paragraph (m) of this Rule, when 
decommissioning involves the entire site, the licensee shall 
request license termination as soon as practicable but no later 
than 24 months following the initiation of decommissioning. 

(m) The agenc\ ma\ approve a request for an alternative 
schedule for completion of decommissioning of the site or 
separate building or outdoor area, and license termination if 
appropriate, if the agenc\ determines that the alternative is 
warranted by consideration of the following: 

(1) \\Tiether it is technicalK feasible to complete 
decommissioning w ithin the allotted 24 month period: 

(2) W'Tiether sufficient waste disposal capacity is 
available to allow completion of decommissioning 
within the allotted 24 month period; 

(3) Whether a significant volume reduction in wastes 
requiring disposal will be achiev ed h\ allowing short- 
lived radionuclides to decav"; 

(4) Whether a significant reduction in radiation exposure 
to workers can be achieved b> allowing short-lived 
radionuclides to decay: and 

(5) Other site-specific factors which the agenc\ may 
consider appropriate on a case-b\-case basis, such as: 
(A) regulator^- requirements of other government 

agencies; 



396 



SORTH CAROLISA REGISTER 



August 14. 1998 



13:4 



PROPOSED RULES 



(B) lawsuits; 

(C) ground-water treatment activities; 

(D) monitored natural ground-water restoration; 

(E) actions that could result in more environmental 
harm than deferred cleanup; and 

(F) other factors beyond the control of the licensee, 
(n) As the final step in decommissioning, the licensee shall: 

(1) Certify the disposition of all licensed material, 
including accumulated wastes, by submitting a 
completed "Certificate of Disposition"; and 

(2) Conduct a radiation survey of the premises where the 
licensed activities were carried out and submit a 
report of the results of this survey unless the licensee 
demonstrates that the premises are suitable for release 
in some other manner. The licensee shall, as 
appropriate: 

(A) Report levels of gamma radiation in units of 
microrem (millisieverts) per hour at one meter 
fi-om surfaces; 

(B) Report levels of radioactivity, including alpha 
and beta, in units of microcuries per 100 square 
centimeters (or disintegrations per minute), 
removable and fixed, for surfaces; microcuries 
per milliliter for water; and picocuries per gram 
for solids such as soils or concrete; and 

(C) Specify the survey instrument(s) used and 
certify that each instrument is properly 
calibrated and tested. 

(o) Specific licenses wtH shall be terminated by written notice 
to the licensee when the agency determines that: 

( 1 ) radioactive material has been properly disposed; 

(2) reasonable effort has been made to eliminate residual 
radioactive contamination, if present; and 

(3) a radiation survey has been performed which 
demonstrates that the premises are suitable for release 
fer — unr e strict e d — use; in accordance with the 
requirements for decommissioning described in Rule 
■ 1653 of this Chapter, or other information submitted 
by the licensee is sufficient to demonstrate that the 
premises are suitable for release for unrestrict e d us e . 
in accordance with the requirements for 
decommissioning described in Rule .1653 of this 
Chapter. 

Authority G.S. I04E-7: 104E-10(b); 104E-I8. 

.0353 FINANCIAL ASSURANCE AND 
RECORD-KEEPING FOR 
DECOMMISSIONING 

(a) Each applicant for a specific license authorizing the 
possession and use of unsealed radioactive material of half-life 
greater than 120 days and in quantities such that R divided by 
10^ is greater than one (unity rule), where R is defined here as 
the sum of the ratios of the quantity of each isotope to the 
applicable value in the table in Appendix C to 10 CFR §§ 
20.1001 - 20.2401 shall submit a decommissioning funding plan 
as described in Paragraph (g) of this Rule. 

(b) Each holder of a specific license issued before the 



effective date of this Rule, and of a type described in Paragraph 
(a) of this Rule shall submit, no later than 60 days after the 
effective date of this Rule, a decommissioning funding plan or 
a certification of financial assurance for decommissioning in an 
amount of at least seven hundred and fifty thousand dollars 
($750,000) in accordance with the criteria set forth in this Rule. 
If the licensee submits the certification of financial assurance 
rather than a decommissioning funding plan at this time, the 
licensee shall include a decommissioning funding plan in any 
application for license renewal. 

(c) Each applicant for a specific license authorizing 
possession and use of radioactive material of half-life greater 
than 120 days and in quantities specified in Paragraph (f) of this 
Rule shall either: 

( 1 ) submit a decommissioning funding plan as described 
in Paragraph (g) of this Rule; or 

(2) submit a certification that financial assurance for 
decommissioning has been provided in the amount 
prescribed by Paragraph (f) of this Rule using one of 
the methods described in Rule .0354 of this Section. 
For an applicant, this certification may state that the 
appropriate assurance will be obtained after the 
application has been approved and the license issued 
but prior to the receipt of licensed material. As part 
of the certification, the applicant shall submit to this 
agency, a copy of the financial instrument obtained to 
satisfy the requirements of Paragraph (g) of this Rule. 

(d) Each holder of a specific license issued before the 
effective date of this Rule, and of a type described in Paragraph 
(c) of this Rule shall submit, no later than 60 days after the 
effective date of this Rule, a certification of financial assurance 
for decommissioning or a decommissioning funding plan in 
accordance with the criteria set forth in this Rule. 

(e) Each holder of a specific license issued on or after the 
effective date of this Rule, which is of a type described in 
Paragraph (a) or (c) of this Rule, shall provide financial 
assurance for decommissioning in accordance with the criteria 
set forth in this Rule. 

(0 Required amounts of financial assurance for 
decommissioning by quantity of radioactive material where R is 
defined as the sum of the ratios of the quantity of each isotope 
to the applicable value in Appendix C to 10 CFR §§ 20.1001 - 
20.2401 are as follows: 

(1 ) for unsealed form, if R divided by 10" is greater than 
one, then the minimum financial assurance amount is 
seven hundred and fifty thousand dollars ($750,000) 
and shall be as stated in an approved 
decommissioning funding plan as described in 
Paragraph (g) of this Rule; 

(2) for unsealed form, if R divided by IC is greater than 
one but R divided by 10' is less than or equal to one, 
then the financial assurance amount is seven hundred 
and fifty thousand dollars ($750,000); 

(3) for unsealed form, if R divided by 10^ is greater than 
one but R divided by 10"' is less than or equal to one. 
then the financial assurance amount is one hundred 
and fifty thousand dollars ($1 50,000); 

(4) for sealed sources or plated foils, if R, divided by 10'° 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



397 



PROPOSED RULES 



is greater than one, then the financial assurance 
amount is seventv' five thousand dollars ($75,000). 

(g) Each decommissioning funding plan shall contain a cost 
estimate for decommissioning and documentation of an 
approved method assuring funds for decommissioning as 
referenced in Rule .0354 of this Section, including means of 
adjusting cost estimates and associated funding levels 
periodically over the life of the facility. 

(h) Each person licensed under this Section of this Chapter 
shall keep records of information important to the safe and 
effective decommissioning of the facility in an identified 
location until the license is terminated by the agency. If records 
of relevant information are kept for other purposes, reference to 
these records and their locations may be used. Information the 
agencN' considers important to decommissioning includes, but is 
not limited to: 

(1) Records of spills or other unusual occurrences 
involving the spread of contamination in and around 
the facilit>', equipment, or site. 

(A) These records may be limited to instances 
when contamination remains after any cleanup 
procedures or when there is reasonable 
likelihood that contaminants ma\,' have spread 
to inaccessible areas as in the case of possible 
seepage into porous materials such as concrete. 

(B) These records shall include any known 
information on identification of involved 
nuclides, quantities, forms, and concentrations. 

(2) As-built drawings and modifications of structures and 
equipment in restricted areas where radioactive 
materials are being tised or stored, and of locations of 
possible inaccessible contamination such as buried 
pipes which ma\' be subject to contamination. 

(A) If required drawings are referenced, each 
relevant document need not be indexed 
individually. 

(B) If drawings are not available, the licensee shall 
substitute appropriate records of available 
information concerning these areas and 
locations. 

(3) Records of the cost estimate performed for the 
decommissioning funding plan or of the amount 
certified for decommissioning, and records of the 
funding method used for assuring funds if either a 
funding plan or certification is used. 

(4) Except for areas containing onK sealed sources 
(provided the sealed sources have not leaked or no 
contamination remains after cleanup of an} leak) or 
radioacti\'e materials having only half-lives of less 
than 65 da\s, or depleted uranium used onh' for 
shielding, licensees shall be required to establish and 
maintain a list, contained in a single document. The 
list shall be updated even, two Nears, and include the 
following information: 

(A) All areas designated and formerK designated 
as restricted areas as defined in Rule .0104 of 
this Chapter: 

(B) All areas outside of restricted areas that require 



documentation under Paragraph (h) of this 
Rule; 

(C) All areas outside of restricted areas where 
current and previous wastes have been buried 
as documented in Rule .1642 of this Chapter: 
and 

(D) All areas outside of restricted areas which 
contain material that, if the license expired, the 
licensee would be required to decontaminate 
either the area to unrestricted release levels or 
to apply to the agency for approval for disposal 
as required in Rule .1629 of this Chapter. 

(i) Prior to license termination, each licensee authorized to 
possess radioactive material in an unsealed form, shall forward 
to the agency the records required in Paragraph (h) of this Rule. 

(jj Before licensed activities are transferred, licensees shall 
transfer all records required in Paragraph (h) of this Rule. In this 
case, the new licensee shall maintain the records until the license 
is terminated. 

Authority- G.S. 104E-7: 104E-18. 

.0359 MEASUREMENTS/DOSAGES OF 
UNSEALED RADIOACTIVE 
MATERIAL FOR MEDICAL USE 

(a) A licensee shall possess and use a dose calibrator to 
measure the radioactivity of dosages of photon-emitting 
radionuclides prior to administration to each individual. A 
licensee shall: 

(1) develop, maintain, and implement written procedures 



12} 



01 



for use of the dose calibrator: 
check dose calibrator for constancy at the beginning 
of each day of use. To satisfy- the requirements of this 
Subparagraph, the check shall be done on a frequently 
used setting with a sealed source of not less than 10 
microcuries (0.37 megabecquerel (MBq) of radium- 
226 or 50 microcuries ( 1.85 MBq) of any other 
photon-emitting radionuclide: 
test each dose calibrator for accuracy upon installation 
and at least annually thereafter by assaying at least 
two sealed sources containing different radionuclides 
who activity the manufacturer has determined within 
five percent of this stated activity', whose acti\'ity is at 
least 10 microcuries (0.37 MBq) for radium-226 and 
50 microcuries (1.85 MBq) for any other photon- 



£4] 



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emitting radionuclide, and at least one of which has a 
principal photon energy between 100 keV and 500 
keV: 

test each dose calibrator for linearity upon installation 
and at least quarterh' thereafter over a range with from 
the highest dosage that will be administered to a 
patient or human research subject to 30 microcuries 
(I.I MBq): and 

test each dose calibrator for geometry dependence 
upon installation over the range of volumes and 
volume configurations for which it will be used. The 
licensee shall keep a record of this test for the 
duration of the use of the dose calibrator. 



398 



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August 14, 1998 



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PROPOSED RULES 



(b) A licensee shall also perform appropriate checks and tests 
required by this Rule following repair of the dose calibrator. 

(c) A licensee shall mathematically correct dosage readings 
for any geometry or linearity error that exceeds 10 percent if the 
dosage is greater than 1 microcuries (.37 MBq) and shall repair 
or replace the dose calibrator if the accuracy or constancy error 
exceeds 1 percent. 

(d) A licensee shall retain a record of each check and test 
required by this Rule for three years. The records required m 
Subparagraphs (a)(2)-(a)(5) of this Rule shall include: 

(1) For Subparagraph (a)(2). the model and serial number 
of the dose calibrator, the identity of the radionuclide 
contained in the check source, the date of the check, 
the activity measured, and the initials of the individual 
who performed the check; 

(2) For Subparagraph (a)(3). the model and serial number 
of the dose calibrator, the model and serial number of 
each source used, the identity of the radionuclide 
contained in the source and its activity, the date of the 
test, the results of the test, and the identity of the 
individual performing the test; 

(3) For Subparagraph (a)(4). the model and serial number 
of the dose calibrator, the calculated activities, the 
measured activities, the date of the test, and the 
identify of the individual performing the test; and 

(4) For Subparagraph (a)(5). the model and serial number 
of the dose calibrator, the configuration of the source 
measured, the activity measured for each volume 
measured, the date of the test, and the identity of the 
individual performing the test. 

Authority' G.S. W4E-7; 104E-10(b): 104E-12. 

.0360 SURVEYS OF RADIOPHARMACEUTICAL 
AREAS FOR CONTAMINATION & 
RADIATION EXPOSURE RATE 

(a) A licensee shall survey with a radiation detection survey 
instrument at the end of each day of use al] areas where 
radiopharmaceuticals are routinely prepared for use or 
administered. 

(b) A licensee shall survey with a radiation detection survey 
instrument at least once each week all areas where 
radiopharmaceuticals or radiopharmaceutical waste is stored. 

(c) A licensee shall conduct the survey required by 
Paragraphs (a) and (b) of this Rule so as to be able to detect dose 
rates as low as 0.1 millirem (1 microsievert) per hour. 

(d) A licensee shall establish radiation dose rate trigger levels 
for the surveys required by Paragraphs (a) and (b) of this Rule. 
A licensee shall require the individual performing the survey to 
promptly notify the Radiation Safety Officer if a dose rate 
exceeds a trigger level. 

(e) A licensee shall survey for removable contamination once 
each week all areas where radiopharmaceuticals are routinely 
prepared for use, administered, or stored. 

(f) A licensee shall conduct the surveys required by Paragraph 
(e) of this Rule so as to be able to detect contamination on each 
wipe sample of 2.000 disintegrations per minute. 

(g) A licensee shall establish removable contamination trigger 



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£5} 



(6} 

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levels for the surveys required by Paragraph (e) of this Rule. A 
licensee shall require the individual performing the survey to 
promptly notify the Radiation Safety Officer if contamination 
levels exceed the trigger level. 

(h) A licensee shall retain a record of each survey required by 
this Rule for three years. The record shall include: 
(1) the date of the survey; 

a plan of each area surveyed; 

the trigger level established for each area; 

the detected dose rate at several points in each area 

surveyed; 

the detected dose rate at several points in each area 

expressed in millirem (or microsievert) per hour or the 

removable contamination in each area expressed in 

disintegrations per minute per 100 square centimeters; 

the instrument used to make the survey or analyze the 

samples; and 

the initials of the individual who performed the 

survey. 
tij Any licensee authorized by the rules of this Chapter to 
manufacture, produce, acquire, receive, possess, use or transfer 
radioactive material for medical use shall have in its possession 
a calibrated portable radiation survey instrument capable of 
detecting dose rates over the range of 0.1 millirem per hour ( 1 
microsievert per hour) to 100 millirem per hour (.01 millisievert 
per hour), and a portable radiation survey instrument capable of 
measuring dose rates over the range of one millirem per hour 
(.01 millisievert per hour) to 1.000 millirem per hour (10 
millisievert per hour). A licensee shall calibrate the survey 
instruments used to show compliance with this Section before 
first use, annually, and following repair. The licensee shall: 

(1) calibrate all scales with readings u p to 1.000 millirem 
(10 millisievert) per hour with a radiation source; 

(2) calibrate two separated readings on each scale that 
must be calibrated; and 

(3) conspicuously note on the instrument the apparent 
exposure rate fi-om a dedicated check source as 
determined at the time of calibration, and the date of 
calibration. 

(i) When calibrating a survey instrument, the licensee shall 
consider a point as calibrated if the indicated exposure rate 
differs from the calculated exposure rate by not more than 20 
percent. 

(k) A licensee shall check each survey instrument for proper 
operation with the dedicated check source each day of use. A 
licensee is not required to keep records of these checks. 

(D A licensee shall retain a record of each survey instrument 
calibration for three years. The record must include: 

(1) a description of the calibration procedure; and 

(2) the date of the calibration, a description of the source 
used and the certified exposure rates from the source, 
and the rates indicated by the instrument being 
calibrated, the correction factors deduced from the 
calibration data, and the identity of the individual who 
performed the calibration. 

Authority G.S. W4E-7; 104E-10(b): 104E-12. 



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399 



PROPOSED RULES 



.0361 MEDICAL USE OF UNSEALED 
RADIOACTIVE MATERIAL 

(a) A licensee ma\' use for diagnostic or therapeutic 
administration anv unsealed radioactive material prepared for 
medical use that is either: 

( 1) obtained from a manufacturer or prepared licensed 
pursuant to 10 CFR 32.72 or equivalent agreement 
state requirements: or 

(2) prepared h\ a pharmacist who is an authorized user. 
a ph\ sician who is an authorized user or an individual 
under the supervision of either. 

(b) A licensee shall not administer to humans a 
radio pharmaceutical containing more than 0.15 microcurie of 
moK'bdenum-99 per millicurie of technetium-99m. 

(c) A licensee that uses moK bdenum-99 technetium-99m 
generators for preparing a technetium-99m radiopharmaceutical 
shall measure the moK bdenum-99 concentration in each eluate 
or extract. 



(d) A licensee that must measure molybdenum concentration 
shall retain a record of each measurement for three \ears. The 
record shall include for each elution or extraction of technetium- 
99m: 



ID 
111 



Aiithorln-G.S. 104E-'(a)l2): 104E-Wlb): 104E-12. 

.0362 DECAY-IN-STORAGE 

(a) A licensee ma\ hold radioacti\e material with a ph\ sical 
half-life of less than 165 daNS for deca\-in-storage before 
disposal in ordinar\ trash and is exempt from the requirements 
of Rule .1628 of this Chapter if the licensee: 

( 1 ) holds radioactive material for deca\ a minimum of 10 
half-li\es: 



(2) monitors radioactive material at the container surface 
before disposal as ordinary trash and determines that 
its radioactivity' cannot be distinguished from the 
background radiation level with a radiation detection 
surve\ meter capable of detecting a dose rate of 0.1 
millirem (J. microsievert) per hour and with no 
interposed shielding: and 

(3) removes or obliterates all radiation labels. 

(b) A licensee shall retain a record of each disposal permitted 
under Paragraph (a) of this Rule for three \ears. The record shall 
include the date of the disposal, the date on which radioactive 
material was placed in storage, the radionuclides disposed, the 
surve>' instrument used, the background dose rate used, and the 
dose rate measured at the surface of each waste container. 



Authority G.S. 104E-7(a)(2>: 104E-I0(b). 

CHAPTER .0500 - SAFETY REQUIREMENTS 
FOR INDUSTRIAL RADIOGRAPHY OPERATIONS 



DEFINITIONS 

used in this Section, the following definitions shall 



the measured activity of the technetium expressed in 
millicuries; 

the measured activity of the moK bdenum expressed in 
microcuries: 

the time and date of the measurement: and 
the initials of the individual who made the 
measurement, 
(e) A licensee that administers radioactive aerosols or gases 
shall: 

( 1 ) do so in a room w ith a s\ stem that \\ ill keep airborne f4-){2} 
concentrations low enough so as not to exceed the 

limits prescribed bv Rules .1604 and .1605 of this 
Chapter; 

(2) before receiving, using or storing a radioactive gas, 
calculate the amount of time needed after a spill to 
reduce the concentration in the room low enough so 

as to not exceed the limits prescribed bv Rules . 1 604 <J4<3) 
and .1605 of this Chapter: 

(3) post the calculated time and safety measures to be 
instituted in the case of a spill at the area of use: 

(4) store volatile radiopharmaceuticals and radioactive 
gases in tlie shipper's radiation shield and container: 
and 

(5) store multi-dose containers in a fume hood or other 
enclosure vented directK to the atmosphere after 
drawing the first dosage from the container. 



.0502 

(a) As 
applv': 

(1) "Annual refresher safety training" means a review 
conducted or provided bv the licensee or registrant for 
its employees on radiation safety aspects of industrial 
radiography. The review mav include, as appropriate, 
the results of internal inspections, new procedures or 
equipment, new or revised regulations, accidents or 
errors that have been observed, and shall also prov ide 



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opportunities for employees to ask safety questions. 
"Associated equipment" means equipment used in 
conjunction with a radiographic exposure device to 
make radiographic exposures that drives, guides or 
comes in contact with the sealed source or radiation 
machin e s, machines [e.g. guide tube, control tube, 
control (guide) tube, removable source stop. "J" tube 
and collimator when it is used as an exposure head]. 
"Cabinet radiography using radiation machines" 
means industrial radiography using radiation 
machines, which is conducted in an enclosed, 
interlocked cabinet, such that the radiation machine 
will not operate unless all openings are securely 
closed, and which cabinet is so shielded that even, 
location on the exterior meets conditions for an 
unrestricted area as specified in Rule .1611 of this 
Chapter. 

"Certifying entity" means an independent certifsing 
organization meeting the requirements in Rule .0525 
of this Section. 

"Collimator" means a d e vic e us e d to radiation shield 
that is placed on the end of the guide tube or directly 
onto a radiographic exposure device to limit the size, 
shape, and direction of the primary radiation b e am. 
when the sealed source is cranked into position, to 
make a radiographic exposure. 
"Control device", commonly called a crank-out, 
means the control cable, the protective sheath and 



400 



SORTH CAROLI.\A REGISTER 



August 14, 1998 



13:4 



will. i«A\K m.ftj.n'fi,itt 



PROPOSED RULES 



control drive mechanism used to move the sealed 
source from the shielded position in the radiographic 
device or camera to an unshielded position outside the 
device for the purpose of making a radiographic 
exposure. (21) 

(7") "Control drive mechanism" means a device that 
enables the source assemblv to be moved to and from 
the exposure device. 

(8) "Control tube" means a protective sheath for guiding (444 (22) 
the control cable. The control tube connects the 
control device mechanism to the radiographic 
exposure device. 
f^9) "Exposure head", commonly called a source stop, 
means a device that locates the gamma radiography 
sealed source in the selected working position. 
(4 ^10) "Field examination" means a d e monstration of 

practical examination, application — of principl es (4 ^23) 
l e arn e d in th e cla s sroom that s hall includ e us e of all 
appropriat e e quipm e nt and proc e dur e s. 

(11) "Field station" means a facility where licensed 
material or registered equipment may be stored or 
used and from which licensed material or registered 
equipment is dispatched. 

(12) "Guide tube" (Projection sheath) means a flexible or (24) 
rigid tube (i.e., "J" tube) for guiding the source 
assemblv and the attached control cable from the 
exposure device to the exposure head. The guide tube 

may also include the connections necessary for (^^4 (25) 

attachment to the exposure device and to the exposure 

head. 

(13) "Hands-on experience" means experience in aU of 
those areas considered to be directly involved in the 
radiography process. (444 (26) 

(14) "Independent certifying organization" means an 
independent organization that meets all of the 
requirements of Rule .0525 of this Section. 

(? 4(15) "Industrial radiography" means the examination of the 
structure of materials by nondestructive methods 
utilizing ionizing s ourc es of radiation, radiation to 
make radiographic images. (27) 

(16) "Lay-barge radiography" means industrial radiography 
performed on any water vessel used for laying pipe. 

(17) "Off-shore platform radiography" means industrial 
radiography conducted from a platform over a body of 
water. 

(8)0-8} "Periodic training" means a periodic review 
conducted or provided by the licensee or registrant for 
its employees on radiation safety aspects of (28) 

radiography. The review shall include the results of 
internal inspections, new procedures or equipment, 
accidents or errors that have been observed, and (4-5 4(29) 
opportunities for employees to ask safety questions. 

(9 4(19) "Permanent radiographic installation" means an 

enclosed shielded room, cell, or vault not located at a (464 (30) 
temporary job-site in which radiography is performed. 
(4& 4(20) "Projection sheath", commonly call e d means a guide 
tube, tube or "J" tub e , m e ans a flexibl e or rigid tub e 
for guiding the sourc e assembly and th e attach e d 



control cabl e from th e e xposure d e vic e to th e 
exposur e h e ad. Wh e n th e sourc e ass e mbly i s fully 
e xt e nd e d to th e e xposur e head, the scal e d sourc e is in 
what is commonly call e d th e working position. 
"Practical examination" means a demonstration 
through practical application of the safety rules and 
principles in industrial radiography including the use 
of all appropriate equipment and procedures. 
"Radiation Saf e ty safety Offic e r" officer" means an 
individual named by the licensee or registrant who has 
knowledge eft of and responsibility fer^ for the overall 
radiation safety program and authorit>' to ensur e 
complianc e with appropriat e radiation protection 
rul e s, standards, and practic e s on behalf of the 
licensee or registrant and who meets the requirements 
of Rule .0510(g) .0510(h) of this Section. 
"Radiographer" means any individual who performs 
or who, in attendance at the site where sources of 
radiation are being used, personally supervises 
industrial radiographic operations and who is 
responsible to the licensee or registrant for assuring 
compliance with the requirements of these Rules and 
all license or registration conditions. 
"Radiographer certification" means written approval 
received from a certifying organization stating that an 
individual has satisfactorily met certain established 
radiation safety, testing, and experience criteria. 
"Radiographer's assistant" means any individual who, 
under the p e rsonal direct supervision of a 
radiographer, uses radiographic exposure devices. 
sources of radiation, related handling tools, or survey 
instruments in industrial radiography. 
"Radiographic exposure device", commonly called a 
camera or projector, means any instrument containing 
a sealed source fastened or contained therein, in 
which the sealed source or shielding thereof may be 
moved, or otherwise changed, from a shielded to 
unshielded position for purposes of making a 
radiographic exposure. 

"Radiographic operations" means all activities 
associated with the presence of radioactive sources in 
a radiographic exposure device during use of the 
device or transport (except when being transported by 
a common or contract transport), to include surveys to 
confirm the adequacy of boundaries, setting up 
equipment and any activity inside restricted area 
boundaries. 

"S-tube" means a tube through which the radioactive 
source travels when inside a radiographic exposure 
device. 

"Sealed source" means any radioactive material that is 
encased in a capsule designed to prevent leakage or 
escape of the radioactive material. 
"Shielded position" means the location within the 
radiographic exposure device or source changer where 
the sealed source is secured and restricted from 
movement. In this position th e radiation e xposur e will 
b e at minimum. This position incorporates maximum 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



401 



PROPOSED RULES 



shielding for the sealed source. 

(4 ^31) "Source assembly" means an assembly that consists of 
the sealed source and a conn e ctor, connector that 
attaches the source to the control cable. 4t The source 
assembly also includes the stop ball if one is used to 
secure the sealed source in the shielded position. The 
connector attaches to the control cable. 

f4^ (32) "Source changer" means a device designed and used 
for replacement of sealed sources in radiographic 
exposure devices, including those also used for 
transporting and storage of sealed sources. 

fW)t33j "Storage area" means any location, facility or vehicle 
which is used to store or secure a radiographic 
exposure device, a storage container or a sealed 
source when it is not in use and which is locked or has 
a physical barrier to prevent accidental exposure, 
tampering with or unauthorized removal of the device, 
storage container or sealed source. 

(304tMJ "Storage container" means a device in which sealed 
sources are secured and stored. 

(344 (35) "Temporary jobsite" means a plac e , location, oth e r 
than a p e rman e nt radiographic installation, where 
s e a le d sourc e s or radiation machin e s ar e pr e s e nt for 
th e purpose of p e rforming radiography, radiographic 
operations are conducted and where licensed material 
may be stored other than those location(s) of use 
authorized on the license. 
(36) "Underwater radiography" means industrial 
radiography performed when the radiographic 
exposure device or related equipment are beneath the 
surface of the water. 
(b) Other detlnitions applicable to this Section may be found 
in Rule .0104 of this Chapter. 



Authority G.S. 104E-7. 

.0503 EQUIPMENT RADIATION LEVEL LIMITS 

(a) Radiographic e xposur e d e vic e s m e asuring l ess than e ith e r 
four inch e s or 10 c e ntim e t e rs from th e s e al e d sourc e storag e 
po s ition to any e xt e rior surfac e of th e device shall hav e no 
radiation l e v e l in e xc e ss of 50 milliro e ntg e ns (0.5 milli s i e v e rts) 
per hour at e ith e r six inch e s or 1 5 c e ntim e t e rs from any e .xt e rior 
surfac e of th e d e vic e . — Radiographic e xposur e d e vic e s. The 
maximum exposure rate limits for source changers and storage 
containers m e a s uring a minimum of e ith e r four inch e s or 10 
centimet e rs from th e s e al e d sourc e storag e po s ition to any 
e xt e rior surfac e of th e d e vic e , and all storage contain e rs for .0507 



se al e d sourc es or out e r contain e rs for radiographic e xposur e 
d e vic es , shall hav e no radiat i on l e v e l in e xc es s of are 200 
mi l liroentgcnG millirem (2 millisieverts) per hour at any exterior 
surface, and ten K) milliro e ntg e n s millirem (0. 1 millisieverts) per 
hour at one meter from any exterior surface. The radiation levels 
specified are vs ith the sealed source in the shielded position. 

(b) Aft e r January 10. 1906 all radiographic e xposure devic e s 
and a s socia te d e quipm e nt oth e r than s torag e contain e rs s hall 
m ee t th e r e quir e m e nt s of Rul e .0521 of this S e ction. 

AiithoritvC.S. 104E-~. 



.0506 SURVEY INSTRUMENTS 

(a) The licensee or registrant shall maintain sufficient 
calibrated and operable radiation survey instruments at each 
temporary jobsite and at any location where sealed sources or 
radiation machines are used or stored to make physical radiation 
surveys as required by this Rule and Rules .1613 and .1627 of 
this Chapter. 

(b) Each radiation survey instrument required by Paragraph 
(a) of this Rule shall be calibrated: 

( 1 ) at intervals not to exceed thr ee six months and after 
each instrument servicing except for battery change; 

(2) at the following points for each instrument, as 
applicable: 

(A) linear scale instruments shall be calibrated at 
two points located approximately 1/3 and 2/3 
of fijll-scale on each scale; 

(B) logarithmic scale instruments shall be 
calibrated at the midrange of each decade and 
at two points in the same decade for at least 
one decade; and 

(C) digital instruments shall be calibrated in 
accordance with procedures approv e d by the 
ag e ncy provid e d that the calibration include s 
include the following calibration points: 

(i) 2 mR/hr or 0.02 mSv/hr; 
(ii) 5 mR/hr or 0.05 mSv/hr; 
(iii) 50 mR/hr or 0.5 mSv/hr; 
(iv) 500 mR/hr or 5 mSv/hr; and 
(v) 1 R/hrorO.Ol Sv/hr; 

(3) so that an accuracy within plus or minus 20 percent of 
the calibration standard can be demonstrated on each 
scale. 

(c) Instrumentation required by this Rule shall have a range 
such that two milliroentgens (0.02 millisieverts) per hour 
through one roentgen (0.01 sievert) per hour can be measured. 

(d) Survey instruments shall be checked for operability prior 
to use. This may be accomplished by evaluating the instrument 
response to the previously measured fields at the projection 
sheath port or the control cable sheath port on a radiographic 
exposure device. 

(e) The licensee or registrant shall maintain records of the 
results of the instrument calibrations in accordance with Rule 
.0523 of this Section. 

Authority- G.S. 104E-7; 104E-1 2(a)(1). 



LEAK TESTING AND REPLACEMENT 
OF SEALED SOURCES 

(a) The replacement of any sealed source fastened to or 
contained in a radiographic exposure device and leak testing of 
any sealed source shall be performed only by persons 
specifically authorized by the agency to do so pursuant to the 
rules in this Section. 

(b) Ttie opening, repair, or modification of any sealed source 
shall be performed only by persons specifically named in a 
license condition to perform that function. 

fb)(cj Each sealed source shall be tested for leakage at 
intervals not to exceed six months. In the absence of a 



402 



NORTH CAROLISA REGISTER 



August 14, 1998 



13:4 



IM^MTWMIgLUL JL'. j'fMMJ.il't.' 



PROPOSED RULES 



certificate from a transferor that a test has been made within the 
six months prior to the transfer, the sealed source shall not be 
put into use until tested. 

{e){dj The wipe of a sealed source shall be performed using 
a leak test kit or m e thod approv e d by th e ag e ncy, similar 
materials and methods. The wipe sample shall be taken from the 
nearest accessible point to the sealed source. The wipe sample 
shall be analyzed for radioactive contamination. The analysis 
shall be capable of detecting 0.005uCi (185 Bq) of radioactive 
material on the test sample and shall be performed by persons 
licensed or registered by the agency to perform such a service. 

(4)(e) Any test conducted pursuant to Paragraphs (b) and (c) 
and (d) of this Rule which reveals the presence of 0.005 
microcurie (185 Bq) or more of removable radioactive material 
shall be considered evidence that the sealed source is leaking. 
The licensee shall immediately withdraw the equipment involved 
from use and shall cause it to be decontaminated and repaired or 
to be disposed of. in accordance with these Rules. A report 
describing the equipment involved, the test results, and the 
corrective action taken shall be submitted in writing to the 
agency at the address in Rule .0111 of this Chapter within five 
days after the test. 

(e){jQ The licensee shall maintain records of the leak test 
results in accordance with Rule .0523 of this Section. 

Authority G.S. 104E-7. 

.0508 QUARTERLY INVENTORY 

(a) Each licensee shall conduct a quarterly physical inventory 
to account for all sealed sources and devices containing depleted 
uranium received and possessed under the license. 

(b) The licensee shall maintain records of the quarterly 
inventory in accordance with Rule .0523 of this Section. 

Authorities. 104E-7: 104E-12{a)fI). 

.0509 UTILIZATION LOGS 

Each licensee or registrant shall maintain current utilization 
logs for inspection by the agency at the address specified in the 
license, showing for each sealed source and radiation machine 
the information required by Rule .0523 .0523(a)(6) of this 
Section. 

Authority G.S. 104E-7: 104E-1 2(a)(1). 

.0510 LIMITATIONS 

(a) The licensee or registrant shall not permit any person to 
act as a radiographer until the person: 

(1) has been instructed in the subjects outlined in Rule 
.0519 of this Section and has demonstrated 
understanding th e r e of; thereof by successful 
completion of a written test. Within two years after 
the effective date of this Rule, the person shall also 
have a minimum of two months of on-the-job training, 
and be certified through a radiography certification 
program by a certifying entity in accordance with the 
requirements of Rule .0525 of this Section: 

(2) has received copies of and instruction in the rules 



contained in this Section and in the applicable rules of 
Sections .0200, .0300, .0900 and .1600 of this 
Chapter, in applicable U.S. Department of 
Transportation regulations referenced in Rule .0117 
of this Chapter, and the licensee's or registrant's 
operating and emergency procedures, and has 
demonstrated understanding th e r e of; thereof by 
successful completion of a written test; 
(3) has received fraining jn the use of the licensee or 
regisfrant's radiographic exposure devices, sealed 
sources, jn the daily inspection of devices and 
associated equipment, and jn the use of radiation 
survey instruments; 

(¥>(4) has demonstrated competence to use the radiographic 
exposure devices, sealed sources, related handling 
tools, radiation machines and survey instruments 
which will be employed in his assignm e nt; assignment 
by successfiil completion of a practical examination 
covering this material; and 

f4-){5j has demonstrated understanding of the instructions in 
Paragraph (a) of this Rule by successfiil completion of 
a written test and a fi e ld e xamination on the subjects 
covered. 

(b) The licensee or registrant shall not permit any person to 
act as a radiographer's assistant until the person: 

(1) has received copies of and instructions in the 
licensee's or registrant's operating and emergency 
procedures, and has demonstrated understanding 
th e r e of; thereof by successfiil completion of a written 
or oral test and practical examination on the subjects 
covered; 

(2) has demonstrated competence to use under the 
personal supervision of the radiographer, the 
radiographic exposure devices, sealed sources, related 
handling tools, radiation machines and radiation 
survey instruments which will be employed in his 
assignment; and 

(3) has demonstrated understanding of the instructions in 
Paragraph (b) of this Rule by successfijlly completing 
a written or oral test and a field examination on the 
subjects covered. 

(c) Records of the training including copies of written tests 
and dates of oral tests and field examinations shall be maintained 
in accordance with Rule .0523 of this Section. 

(d) Each licensee or registrant shall conduct an internal audit 
program to ensure that the agency's radioactive material license, 
registration conditions and the licensee's or registrant's operating 
and emergency procedures are followed by each radiographer 
and radiographer's assistant. These internal audits shall be 
performed and records maintained by the licensee or registrant 
as specified in Sub it e ms (3)(a) and (b) Items (3) and (4) of Rule 
.0323 of this Chapter. 

(e) The licensee or registrant shall provide periodic training 
for radiographers and radiographer's assistants at least once 
during every 12 months. 

(f) Whenever radiography is performed outside of a 
permanent radiographic installation, the radiographer shall be 
accompanied by another qualifi e d radiographer or an individual 



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403 



PROPOSED RULES 



with, at least, the qualifications of a radiographer's assistant. 
This person's responsibilities shall include but not be limited to 
observing the operations and being capable and prepared to 
provide immediate assistance to prevent unauthorized entr\. 
Unless oth e nvis e authoriz e d by th e ag e ncy, radiography shall not 
bo perform e d if only one qualifi e d individual i s present. 

(g) A licensee or registrant ma\ conduct lav-barge, off-shore 
platform, or underwater radioaraphv onK if detailed procedures 
have been developed and submitted to the agencN' that ensure 
radiation exposure to the workers and the public are ALARA 
during the radiographic operation. 

fg^h) The radiation safety officer shall ensure that radiation 
safet) acti\ities are being performed in accordance with 
approved procedures and regulatory requirements in the daih' 
operation of the licensee's or registrant's program. 

(1) The radiation safety officer's qualifications shall 
include: 

(A) completion of the training and testing 
requirements of Paragraph (a) of this Rule: and 

(B) Two years thousand hours documented 
experience in industrial radiographic 
operations, with at least 40 hours of formal 
classroom training \\\x\\ respect to the 
establishment and maintenance ov e rsight of 
radiation protection programs or an equivalent 
combination of education and experience. 

(2) The specific duties and authorities of the radiation 
safety officer shall include, but are not limited te^ to 
the following: 

(A) to establish and oversee operating, emergency 
and ALARA procedures, and to review them 
regularly to assure that the procedures are 
current and conform with these Rul e s; Rules 
and to the license conditions: 

(B) to oversee and approve all phases of the 
training of radiographic personnel so that 
appropriate and effective radiation protection 
practices are taught: 

(C) to ensure that required radiation surveys and 
leak tests are performed and documented in 
accordance with this Rule, including any 
corrective measures w hen levels of radiation 
exceed established limits: 

(D) to ensure that personnel monitoring devices are 
calibrated and used properly b> occupational K- 
exposed personnel, that records are kept of the 
monitoring results, and that timely notifications 
are made as required b\ Rule .1646 of this 
Chapter; 

(E) to assure that operations are conducted safeK- 
and to assume control and have the authority to 
institute corrective actions including stopping 
of operations when necessary in emergencN 
situations or unsafe conditions. 

(h) NoUvith s tanding th e pro\ isions of Paragraph (g) of thi s 
Rul e . an> p e rson authoriz e d b> license or r e gistration condition 
to se r\ e as th e radiation saf e ty officer on th e e ff e ctiv e dat e of 
this Rul e , s hall not b e r e quir e d to me e t th e training requir e m e nts 



in Subparagraph (g)(1) of this Rul e imtil Octob e r 1, 1996. 

Authorit}- G.S. 104E-7: 10 C.F.R. Chapter 1, Commission 
Sotices, Policy Statements, Agreement States. 46 F.R. 7540. 

.0511 INSPECTION AND MAINTENANCE 

(a) Th e lic e nsee or r e gistrant shall conduct a program for 
insp e ction and maint e nanc e of radiographic expo s ur e d e vic e s, 
storag e containers, sourc e chang e rs, radiation machin e s and 
associated equipment at intervals not to exceed thr ee months or 
prior to th e first u se th e r e aft e r to a s sur e prop e r functioning of 
compon e nt s important to s af e ty. R e cords of th e s e insp e ctions 
and maint e nanc e shall b e mad e in accordanc e with Rul e .0523 
of this S e ction. If d e f e cts ar e found, th e aff e ct e d radiographic 
e xposur e d e vic e s, storag e contain e rs, sourc e chang e rs, radiation 
machin e s and associat e d e quipm e nt shall be r e mov e d from 
se rvic e until repaired and a record made in accordanc e with Rule 
.0523 of thi s S e ction. 

fb^(a) Prior to use each day, the licensee or registrant shall 
visually check for obvious defects in radiographic exposure 
devices, storage containers, source changers, radiation machines 
and associated equipment. The purpose of the visual check is to 
assure that the radiographic exposure devices, storage 
containers, source changers, radiation machines and associated 
equipment are in good working condition and that the required 
labeling is present. If defects are found, the affected 
radiographic exposure devices, storage containers, source 
changers, radiation machines and associated equipment shall be 
removed from service until repaired and a record shall be made 
in accordance with Rule .0523 of this Section. 

(e¥b) Each exposure device using depleted uranium (DU) 
shielding and an "S" tube configuration shall be tested for DU 
contamination at intervals not to exceed 12 months. This test 
shall be performed by the licensee using procedures approved b)' 
the agency pursuant to Rule .0323 of this Chapter or by the 
licensee returning the exposure de\ ice to the manufacturer for 
such testing. If the test reveals the presence of DU 
contamination, the exposure device shall be removed from use 
and arrangements for proper disposal shall be made. 

(c) Each licensee or registrant shall have written procedures 
for: 

(1) inspection and maintenance or radiographic exposure 
devices, transport and storage containers, source 
changers. sur\e\- instruments, radiation machines and 
associated equipment at intervals not to exceed three 
months or prior to the first use thereafter to assure 
proper functioning of components important to safet%. 



Records of these inspections and maintenance shall be 
made in accordance with Rule .0523 of this Section. 



If defects are found, the affected radioi^raphic 
exposure and associated equipment shall be removed 
from service until repaired and a record made in 
accordance with Rule .0523 of this Section. 
(2) inspection and maintenance necessan to maintain 
T\pe B packaging used to transport radioactive 
materials. The inspection and maintenance program 
shall include procedures to assure that Tvpe B 
packages are shipped and maintained in accordance 



404 



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August 14, 1998 



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PROPOSED RULES 



with the certificate of compliance or other approval. 
(d) Records of equipment problems and of any maintenance 
performed under Paragraphs (a) and £bj of this Rule shall be 
made in accordance with Rule .0523 of this Section. 

Authority G.S. 104E-7. 



Rule .0523 of this Section. 

(h) Notwithstanding the requirements of Paragraph (a) of this 
Rule, the agency may approve a higher pocket dosimeter range 
upon written request by the licensee or registrant if the agency 
determines that the requested range will afford the protection 
required by the rules in this Chapter. 



.0512 PERSONNEL MONITORING 

(a) The licensee or registrant shall not permit any individual 
to act as a radiographer or a radiographer's assistant unless, at all 
times during radiographic operations, each such individual wears 
on the trunk of the body a direct reading pocket dosimeter, an 
operating alarm ratemeter, and either a film badge or a 
thermolimiinescent dosimeter (TLB) exc e pt that for (TLD). At 
permanent radiography facilities where other appropriat e 
alarming or warning devices are in routine use, the wearing of an 
alarming ratemeter is not required. Pocket dosimeters shall have 
a range from zero to 200 milliroentgens (2 millisieverts) and 
shall be recharged at the start of each shift. Electronic personal 
dosimeters may only be used in place of ion-chamber pocket 
dosimeters. Each film badge and TLD shall be assigned to and 
worn by only one individual. Film badges and TLB s shall be 
exchanged at least monthly, monthly and TLBs shall be 
exchanged at least once each three months. After exchange, 
each film badge or TLB shall be promptly processed. 

(b) Pock e t Birect reading dosimeters such as electronic 
dosimeters or pocket dosimeters shall be read and exposures 
recorded at the beginning and end of each shift. 

(c) Pocket dosimeters or electronic personal dosimeters shall 
be checked at periods not to exceed 12 months for correct 
response to radiation. Acceptable dosimeters shall read within 
plus or minus M 20 percent of the true radiation exposure. 

(d) If an individual's pocket dosimeter is found to be off- 
scale, and the possibility of radiation exposure cannot be ruled 
out as the cause, their film badge or TLB shall be immediately 
sent for processing. In addition, the individual shall not work 
with sealed sources until a determination of his radiation 
exposure has been made by the radiation safety officer or his 
designee. 

(e) If a film badge or TLB is lost or damaged, the worker 
shall cease work immediately until a replacement film badge or 
TLB is provided and exposure is calculated for the time period 
from issuance to loss or damage of the film badge or TLB. 

(f) Each alarm ratemeter shall: 

( 1 ) be checked to ensure that the alarm fimctions properly 
prior to use at the start of each shift; 

(2) be set to give an alarm signal at a preset rate not to 
exceed 500 mR/hr or 5 mSv/hr; 

(3) require special means to change the preset alarm 
function; 

(4) alarm within plus or minus 20 percent of the true 
radiation rate; 

(5) be calibrated at periods not to exceed one year for 
correct response to radiation. 

(g) Records of daily dosimeter readings, determination of 
exposure as a result of a lost or damaged film badge or TLB, 1 2 
month response checks on dosimeters and results from the film 
badge or TLB processor shall be maintained in accordance with 



Authority G.S. 104E-7; 104E-12(a)(2). 

.0513 OPERATING AND EMERGENCY 
PROCEDURES 

TTie licensee's or registrant's operating and emergency 
procedures shall include instructions in at least the following: 

( 1 ) the handling and use of licensed sealed sources of 
radiation and radiographic exposure devices to be 
employed such that no individual is likely to be 
exposed to radiation doses in excess of the limits 
established in Rule .1604 of this Chapter; 

(2) methods and occasions for conducting radiation 
surveys; 

(3) methods for controlling access to radiographic areas; 

(4) methods and occasions for locking and securing 
radiographic exposure devices, transport and storage 
containers and sealed sources of radiation; 

(5) personnel monitoring and the use of personnel 
monitoring equipment; 

(6) transportation of sealed sources to field locations, 
including packing of radiographic exposure devices, 
and storage containers s e al e d sourc e s in the vehicles, 
posting placarding of vehicles, and control of sealed 
sources during transportation; 

(7) minimizing exposure of individuals in the event of an 
accident; 

(8) the procedure for notifying proper personnel in the 
event of an accident; 

(9) maintenance of records; 

(10) the inspection and maintenance and operability checks 
of radiographic exposure devices, radiation machin e s 
machines, survey instruments, transport containers. 
and storage containers; 

(11) steps that shall be taken immediately by radiography 
personnel in the event a pocket dosimeter is found to 
be off s cal e ; scale or an alarm ratemeter alarms 
unexpectedly; and 

(12) sealed source recovery procedure if the licensee will 
perform sealed source recovery. 

Authority^ G.S. 104E-7. 



.0515 RADIATION SURVEYS AND 
SURVEY RECORDS 

(a) No radiographic operation shall be conducted unless 
calibrated and operable radiation survey instrumentation as 
described in Rule .0506 of this Section is available and used at 
each site where radiography is performed, including sealed 
source exchange and at the storage area whenever a radiographic 
exposure device, a storage container or sealed source is being 
placed in storage. 



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405 



PROPOSED RULES 



(b) A survey with a radiation detection instrument shall be 
made after each radiographic exposure to determine that the 
sealed source has returned to its shielded position in the 
radiographic exposure device or the radiation machine is off. 
For sealed sources, the licensee shall conduct a survey of the 
guide tube as the radiographer or radiographer's assistant 
approaches the camera camera, and th e e ntir e circumf e r e nc e of 
th e camera wh e n th e radiograph e r or radiograph e r' s a ss i s tant 
r e ach es it The survey must determine that the sealed source has 
returned to its shielded position prior to exchanging films, 
repositioning the collimator exposure head or dismantling the 
radiographic exposure device and associated equipment. 

(c) When the use of a radiographic exposure device or storage 
container is to be terminated at the end of a work period, a 
surve\' with a radiation detection instrument shall be made of the 
locked radiograph) device or storage container to determine that 
the sealed source is in its shielded position. 

(d) A survey of the radiographic exposure device and source 
changer shall be performed with a radiation detection instrument 
any time the sealed source is exchanged and whenever a 
radiographic exposure device is placed in a storage area. 

(e) An area survey of the perimeter of the restricted area with 
a radiation detection instrument shall be made with the sealed 
source exposed or the radiation machine on before or during the 
initial radiographic exposure on each shift and when the sealed 
source or the radiation machine target configuration for an 
exposure is substantially different from that of the preceding 
e xposur e , exposure such that the radiation exposure rate at the 
perimeter of the restricted area js likelv to increase by a 
measurable amount using a radiation detection instrument. 
These surveNS are not required for radiography performed in a 
permanent radiographic installation. 

(f) Records of surveys required by this Rule shall be 
maintained in accordance with the requirements of Rule .0523 
of this Section. 

Authority G.S. I04E-7: J04E-12la/(l). 

.0516 POSTING 

Notwithstanding any provisions in Rule .1625 of this Chapter, 
areas in which radiograph) is being performed shall be 
conspicuous!) posted as required b) Rule .1624 of this Chapter 
The exception listed in Rule .1625 of this Chapter does not appK 
to industrial radiography. 



( 1 ) the radiographer's p e rsonal physical presence at the 
site where the sealed sources or radiation machines 
are being used; 

(2) the ability availability of the radiographer to give 
immediate assistance, if required; and 

(3 ) the radiographer's watching direct observation of the 
assistant's performance of the operations referred to in 
this Section. 

Authority G.S. 104E-7. 

.0520 PERMANENT RADIOGRAPHIC 
INSTALLATIONS 

(a) Permanent radiographic installations having high radiation 
area entrance controls of the types described in Subparagraphs 
(a)(1). (2) and (3) of Rule .1615 of this Chapter shall also meet 
the following special requirements: 

( 1 ) Each entrance that is used for personnel access to the 
high radiation area in a permanent radiographic 
installation to which this Section applies shall have 
both visible and audible warning signals to warn of 
the presence of radiation. 

(2) The visible signal shall be actuated by radiation 
whenever the sealed source is exposed. 

(3) The audible signal shall be actuated when an attempt 
is made to enter the installation while the sealed 
source is exposed. 

(b) The alarm system shall be tested for proper operation at 
int e rval s not to e xceed throe months and with a radiation source 
at the beginning of each da)' of equipment use. The daily test 
shall include a check of the visible and audible signals by 
exposing the sealed source or operating the radiation machine 
prior to use of the room. Entrance control devices that reduce the 
radiation level upon entry as required jn Paragraph (a) ofthis 
Rule shall be tested monthK. If a control device or alarm is 
operating improperly, it shall immediately be labeled as 
defective and repaired within seven calendar da\s. The facility 
may continue to to be used during this seven day period, 
provided the licensee or registrant implements continuous 
surveillance to protect against unauthorized entry and uses an 
alarming ratemeter. b e for e industrial radiographic op e rations ar e 
r e sum e d. 

(c) Records of test of alarm flmctions shall be maintained in 
accordance with Rule .0523 ofthis Section. 



Authority' G.S. 104E- 



Authorit\G.S. 104E-'': I04E-12fa)(l). 



.0517 SUPERVISION OF RADIOGRAPHERS' 
ASSISTANTS 

(a) Whenever a radiographer's assistant uses radiographic 
exposure de% ices or radiation machines, uses sealed sources or 
related source handling tools, or conducts radiation surveys 
required by Rule .0515(b) and (c) ofthis Section to determine 
that the exposure has been terminated and. if applicable, the 
sealed source has returned to the shielded position after an 
exposure, he the assistant shall be under the personal supervision 
of a radiographer 

(b) The personal supervision shall include: 



.0521 PERFORMANCE REQUIREMENTS 
FOR RADIOGRAPHY EQUIPMENT 

Equipment used in industrial radiographic operations shall 
meet the following minimum criteria: 

( 1 ) Each radiographic exposure d e vic e device, source 
assembly or sealed source, and all associated 
equipment shall meet the requirements specified in 
American National Standard N 4 3.9 1991 N432-1980 
"Radiological Safety for the Design and Construction 
of Apparatus for Gamma Radiograph)". This 
publication is incorporated by reference in Rule .0117 



406 



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August 14, 199H 



13:4 



PROPOSED RULES 



■^■^M^IUMilUi. J. ■».u».».i. f^r^n 









of this Chapter. 
(2) Engineering analysis may be submitted to the agency 
to demonstrate the applicability of preyiously 
performed testing on similar individual radiography 
equipment components. Upon review by the agency, 
this may be an acceptable alternative to actual testing 
of the component pursuant to the above referenced 
standard. 
(3){3} In addition to the requirements specified in Item ( 1 ) of 
this Rule, the following requirements apply to 
radiographic exposure d e vic e s — an^ — associat e d 
equipm e nt: devices, source changers, source 
assemblies, and sealed sources: 

(a) Each radiographic exposure device shall have 
attached to it by the user a durable, legible, 
clearly visible label bearing the following: 

(i) Chemical symbol and mass number of 

the radionuclide in the device; 
(ii) Activity and the date on which this 

activity was last measured; 
(iii) Model number (or product code) and 

serial number of the sealed source; 
(iv) Manufactur e r Manufacturer's identity of 

the sealed source; and 
(v) Licensee's name, address, and telephone 

number. 

(b) Radiographic exposure devices intended for 
use as Type B transport containers shall meet 
the applicable requirements of 10 CFR Part 71 . 

(c) Modification of any radiographic exposure 
d e vic e s devices, source chargers and source 
assemblies and associated equipment is 
prohibited, unless the design of any 
replacement component, including sealed 
source holder, source assembly, controls or 
guide tubes would not compromise the design 
safety features of the system. 

f^4) In addition to the requirements specified in Items ( 1 ) 
and (3) (3} of this Rule, the following requirements 
apply to radiographic exposure devices devices, 
source assemblies, and associated equipment that 
allow the sealed source to be moved out of the device 
for routin e radiographic op e ration, operations or to 
source changers. 

(a) The coupling between the source assembK and 
the control cable shall be designed in such a 
manner that the source assembly will not 
become disconnected if cranked outside the 
guide tube. The coupling shall be such that it 
cannot be unintentionally disconnected under 
normal and reasonably foreseeable abnormal 
conditions. 

(b) The device shall automatically secure the 
source assembly when it is cranked back into 
the fully shielded position within the device. 
This securing system shall be designed to only 
allow release of the sealed source bj means of 
a deliberate operation on the exposure device. 



(c) The outlet fittings, lock box. and drive cable 
fittings on each radiographic exposure device 
shall be equipped with safety plugs or covers 
which shall be installed during storage and 
transportation to protect the source assembly 
from water, mud. sand or other foreign matter. 

(d) Each sealed source or source assembly shall 
have attached to it or engraved in it. a durable, 
legible, visible label with the words: 
"DANGER-RADIOACTIVE." The label shall 
not interfere with the safe operation of the 
exposure device or associated equipment, 

(e) The guide tube shall have passed the must be 
able to withstand a crushing tests test for th e 
control tub e a s s p e cifi e d in ANSI N'132 that 
closely approximates the crushing forces that 
are likely to be encountered during use, and be 
able to withstand a kinking resistance test that 
closely approximates the kinking forces that 
are likely to be encountered during use. 

(0 Guide tubes shall be used when moving the 
sealed source out of the device. 

(g) An exposure head or similar device designed to 
prevent the source assembly from passing out 
of the end of the guide tube shall be attached to 
the outermost end of the guide tube during 
radiographic operations. 

(h) The guide tube exposure head connection shall 
be able to withstand the tensile test for control 
units specified in ANSI N432. 

(i) Source changers shall provide a system for 
assuring that the sealed source will not be 
accidentally withdrawn from the changer when 
connecting or disconnecting the drive cable to 
or from a source assembly. 
{4) — AH — n e wly — manufactur e d — radiographic — e xposur e 

d e vic e s — and — associat e d — e quipment — acquir e d — by 

lic e nsees after the e ff e ctive date of this Rul e shall 

comply with th e requir e ments of this Rule. 
{4^ All radiographic e xpo s ur e d e vic es , s ource assemblies 

and a s sociat e d e quipm e nt in u se aft e r Januarys 10. 

1996 shall comply with th e r e quir e m e nt s of thi s Rul e . 
ffr)(5) All associated equipment acquired after January 10, 

1996 shall be labeled to identify that the components 

have met the requirements of this Rule. 

Authorin-G.S. 104E-7. 

.0522 REPORTING REQUIREMENTS 

(a) In addition to the reporting requirements specified in other 
rules of this Chapter, each licensee or registrant shall provide a 
written report to the agency at the address specified in Rule 
.0111 of this Chapter within 30 days of the occurrence of any of 
the following incidents involving radiographic equipment: 

(1) unintentional disconnection of the source assembly 
from the control cable; 

(2) inability to retract the source assembly to its fully 
shielded position and secure it in this position; or 



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August 14, 1998 



407 



PROPOSED RULES 



(3) failure of any component critical to safe operation of 
the device to properly perform its intended function. 

(b) The licensee or registrant shall include the following 
information in each report required by Paragraph (a) of this 
Rule, and in each report of overexposure submitted pursuant to 
Section .1600 which involves failure of safety components of 
radiography equipment: 

( 1 ) a description of the equipment problem; 

(2) cause of each incident, if known; 

(3) manufacturer and model number of equipment 
involved in the incident; 

(4) place, time and date of the incident; 

(5) actions taken to establish normal operations; 

(6) corrective actions taken or planned to prevent 
recurrence; and 

(7) qualifications of personnel involved in the incident. 

(c) Any licensee or registrant conducting radiographic 
operations or storing radioactive material at any location not 
listed on the license for a period in excess of 180 days in a 
calendar year, shall notify the agency prior to exceeding the 180 
days. 

Authority- G.S. 104E-7. 

.0523 RECORDS OF INDUSTRIAL 
RADIOGRAPHY 

(a) Each licensee or registrant shall maintain, for a period of 
three years after the record is mad e made, or until th e ag e ncy 
authoriz e s disposition, the following records for inspection by 
the agenc> : 

( 1 ) copies of the following documents; 

(A) radioactive materials license or registration 
issued by the agency; 

(B) the complete application submitted for the 
license or registration that includes all 
amendments; and 

(C) current operating and emergency procedures; 

(2) records showing the receipt and transfer of all sealed 
sources and devices using depleted uranium (DU) for 
shielding that include: 

(A) date; 

(B) individual making the record; 

(C) radionuclide; 

(D) activity in curies or b e cqu e r e l; becquerel or 
mass for depleted uranium; and 

(E) make, model and serial number of each sealed 
source and device; 

(3) records of the calibrations of radiation detection 
instrumentation; 

(4) records of leak tests for sealed sources and devices 
containing depleted uranium in units of microcuries or 
becquerel; 

(5) records of quarterly inventories that include: 

(A) radionuclide; 

(B) activity in curies or becquerel: 

(C) specific information on each sealed source and 
the radiographic exposure device, storage 
container or source changer which contains the 



(6) 



(7) 



(8) 



(9) 



sealed source to include: 
(i) model numbers; 
(ii) serial numbers; and 
(iii) manufacturers names; 

(D) location of sealed sources; 

(E) name of the individual conducting the 
inventory; and 

(F) the date of the inventory; 

records of utilization logs showing the following 
information: 

(A) a description of each radiographic exposure 
device, radiation machine or transport or 
storage container in which the sealed source is 
located that includes: 

(i) make; 

(ii) model number; and 
(iii) serial number; 

(B) the identity and signature of the radiographer to 
whom assigned; and 

(C) the plant or site where used; and 

(D) dates of use that includes the dates removed 
and returned to storage; 

records of inspection and maintenance of radiographic 
exposure devices, transport and storage containers, 
associated equipment, source changers and radiation 
machines. The record shall include: 



(A) 
(B) 
(C) 
(D) 

(E) 



wm 



date of the check; 

name of the individual performing the check; 
equipment involved; 

any d e f e cts problems found; found in daily 
checks and quarterly inspections; and 
any repairs or maintenance made and name of 
individual or company performing the repair; 
records of alarm system tests for permanent 
radiographic installations; 

records of the training and certification of each 
radiographer and radiographer's assistant as follows: 
(A) radiographer certification documents and 
verification of certification status; 
for initial training, copies of written tests, dates 
and results of oral tests and field examinations; 
and names of individuals conducting and 
receiving the oral test or field examination; 
fB4(C) for periodic training, training and semi-annual 
inspections of job performance, list of topics 
discussed, date(s) of the Fe¥i«w review, names 
of the instructors and the attendees; and 
(D) for inspections of job performance, the records 
shall also include a Mst showing the items 
checked a nd any noncompliance observed by 
the Radiation Safety Officer. 

(10) records for pocket dosimeters to include daily 
exposure readings and yearly operability checks; 

(11) records of reports received from the film badge or 
TLD processor. These records shall be maintained 
until the agency terminates the license or registration 
or until authorized by the agency; 

(12) records of exposure device surveys performed at the 



40H 



NORTH CAROLINA REGISTER 



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13:4 



HMUMUilBEq 



PROPOSED RULES 



(13) 
(14) 



end of the work day and prior to placing the device in 
storage; and 

records of area surveys required by Rule .05 1 5 of this 
S e ction. Section; 



copy of current operating and emergency procedures 
until the agency terminates the license or registration 
and copies of superseded material shall be retained for 
three years after the change is made; and 
(15) evidence of the latest calibrations of alarm ratemeters 
and operability checks of pocket dosimeters or 
electronic personal dosimeters. 

(b) Each licensee or registrant conducting operations at 
temporary jobsites shall maintain copies of the following 
documents and records at the temporary jobsite until the 
radiographic operation is completed: 

( 1 ) operating and emergency procedures required by Rule 
.0513 of this Section; 

(2) radioactive materials license or registration; 

(3) evidence of training of the radiographers and 
radiographer's assistants. The individuals shall either 
be listed on the radioactive materials license or 
registration and offer prop e r identification or shall 
have certification of his training and offer prop e r 
identification; 

(4) evidence of the latest calibration of the radiation 
detection instrumentation in use at the site as required 
by Rule .0506 of this Section; 

(5) evidence of the latest leak test of the sealed source 
required by Rule .0507 of this Section; 

(6) records of the latest surveys required by Rule .05 1 5 of 
this Section; 

(7) records of current direct reading dosimeters such as 
pocket dosimeter or electronic personal dosimeter 
readings; 

(8) shipping papers for the transportation of radioactive 
materials required by 10 CFR Part 71.5; and 

(9) records of area surveys required by Rule .05 1 5 of this 
S e ction. Section; 

(10) a copy of Section .0500 of this Chapter; 

(11) utilization records for each radiographic exposure 
device dispatched from that location as required by 
Subparagraph (a) of Rule .0523 of this Section; 

(12) records of equipment problems identified in daily 
checks of equipment; and 

(13) when operating under reciprocity, a copy of the 
Nuclear Regulatory Commission or agreement state 
license authorizing the use of radioactive material. 

(c) Each record required by this Rule shall be legible 
throughout the specified retention period. The record may be an 
original, a reproduced copy or microform provided that the copy 
or microform is authenticated by authorized p e r s onn e l the 
licensee and that the microform is capable of reproducing a clear 
copy throughout the required record retention period. The 
record may also be stored in electronic media with the capability 
for producing legible, accurate and complete records during the 
required record retention period. Records, such as letters, 
drawings and specifications shall include all pertinent 
information, such as stamps, initials and signatures. The 



licensee or registrant shall maintain safeguards against tampering 
with and loss of records. 

Authorities. 104E-7. 

.0524 SPECIFIC LICENSE FOR INDUSTRIAL 
RADIOGRAPHY 

An application for a specific license for the use of licensed 
material in industrial radiography shall be approved if the 
applicant meets the following requirements: 

(1) the applicant satisfies the general requirements 
specified in Rules .0317 and .0323 of this Chapter for 
radioactive material, as appropriate, and any special 
requirements contained in this Section; 

(2) the applicant submits a program for training 
radiographers and radiographers' assistants, that meets 
the requirements of Rule .0323 of this Chapter and 
Rule .0510 of this Section. 

(3) the applicant submits procedures for verifying and 
documenting the certification status of radiographers 
and for ensuring that the certification of individuals 
acting as radiographers remains valid; 

(4) the applicant submits written operating and 
emergency procedures as described in Rule .0323 of 
this Chapter and Rule .0513 of this Section; 

(5) the applicant submits a description of a program for 
inspections of the job performance of each 
radiographer and radiographers' assistant at intervals 
not to exceed six months as described in Rule .0323 
of this Chapter; 

(6) the applicant submits a description of the applicant's 
overall organizational structure as it applies to the 
radiation safety responsibilities jn industrial 
radiography, including specified delegation of 
authority and responsibility; 

(7) the applicant identifies and lists the qualifications of 
the individual(s) designated as thie radiation safety 
officer and potential designees responsible for 
ensuring that the licensee's radiation safety program is 
implemented in accordance with the requirements of 
this Chapter; 

(8) If an applicant intends to perform leak testing of 
sealed sources or exposure devices containing 
depleted uranium shielding, the applicant shall 
describe the procedures for performing and the 
qualifications of the person(s) authorized to do the 
leak testing. If the applicant intends to analyze its 
own wipe samples, the application shall include a 
description of thie procedures to be followed. The 
description shall include the: 

(a) instruments to be used; 

(b) methods of performing the analysis; and 

(c) pertinent experience of tlie person who will 
analyze the wipe samples; 

(9) if tlie applicant intends to perform "in-house" 
calibrations of survey instruments, the applicant shall 
describe methods to be used and the relevant 
experience of the person(s) who will perform the 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



409 



PROPOSED RULES 



calibrations. Ail caiibrations shali be performed 
according to the procedures described and at the 
intervals prescribed [n Rule .0506 of this Section; 

( 10) The applicant identities and describes the location(s) 
of all tleld stations and permanent radiographic 
installations: and 

(11) The applicant identifies the locations where all 
records required b\ this Section and other Sections of 
this Chapter will be maintained. 

Authority- G.S. 104E-^: 1 04 E- 10(b). 



.0525 

(a) An 



t2J 

01 
£4} 



L8J 



m 



(10) 



LiU 



RADIOGRAPHER CERTIFICATION 

independent certifying organization shall: 

be an organization such as the American Society of 

Nondestructive Testing (ASNT) or other society or 

association, whose members participate in, or have an 

interest in. the field of industrial radiography: 

make its membership available to the general public 

nationwide that is not restricted because of race. 

color, religion, sex, age, national origin or disability: 

have a certification open to nonmembers. as well as 

members: 

be an incorporated, nationally recognized 

organization, such as ASNT. that is involved in 

setting national standards of practice within its field 

of expertise: 

have staff a viable system for fmancing its 

operations, and policy and decision-making review 

board: 

have a set of written organizational by-laws and 

policies that provide assurance of lack of conflict of 

interest and a system for monitoring and enforcing 

those by-laws and policies: 

have a committee, whose members can carry out their 

responsibilities impartialK. to review and approve the 

certification guidelines and procedures, and to advise 

the organization's staff in implementing the 

certification program: 

have a committee, whose members can carry out their 

responsibilities impartially, to review complaints 

against certified individuals and to determine 

appropriate sanctions: 

have written procedures describing aH aspects of its 

certification program, maintain records of the current 

status of each individual's certification and the 

administration of its certification program: 

have procedures to ensure that certified individuals 

are provided due process with respect to the 

administration of its certification program, including 

the process of becoming certified and any sanctions 

imposed against certified individuals: 

have procedures for proctoring examinations. 

including qualifications for proctors: 

ensure that the procedures in Subparagraph (a)( 1 1 ) of 

this Paragraph require that the individuals proctoring 

each examination are not employed by the same 

company or corporations (or a wholly -owned 



subsidiary of such company or corporation) as any of 
the examinees: 

(13) exchange information about certified individuals with 
the agency and other independent certifying 
organizations or the U.S. Nuclear Regulatory 
Commission and other agreement states, and allow 
periodic review of its certification program and 
related records: and 

(14) provide a description to the agency of its procedures 
for choosing examination sites and for providing an 
environment suitable for examination. 



tb] All 



£2J 



certification programs shall: 

require applicants for certification to receive training 
in the topics set forth in Rule .0519 of this Section 
and satisfactorily complete a written examination 
covering the topics in Rule .0519 of this Section: 
require applicants for certification to provide 
documentation that demonstrates that the applicant 
has: 

(A) received training in the topics set forth in Rule 
.0519 of this Section: or 

(B) satisfactorily completed a minimum period of 
on-the-job training: and 

(C) received verification by an agreement state or 
a Nuclear Regulatory Commission licensee that 
the applicant has demonstrated the capability of 
independently working as a radiographer: 

(3) include procedures to ensure that all examination 
questions are protected for disclosure: 

(4) include procedures for denying an application, and for 
revoking, suspending, and reinstating a certification: 

(5) provide a certification period of not less than three 
years and not more than five years: 

(6) include procedures for renewing certifications and, if 
the procedures allow renewals without examination, 
require evidence of recent full-time employment and 
annual refresher training: and 

(7) provide a timely response to inquiries by telephone or 
letter, from members of the public, about an 
individual's certification status. 

(c) All examinations shall be: 
(1) designed to test an individual's knowledge and 
understanding of the topics set forth in Rule .0519 of 
this Section: 

written in a multiple-choice format: and 
have test items drawn from a question list based on 
the material contained in Rule .0519 of this Section. 



12] 
01 



Authority G.S. 104E-7: 104E-10(l). 

SECTION .0700 - USE OF SEALED 

RADIOACTIVE SOURCES IN 

THE HEALING ARTS 

.0702 INTERSTITIAL: INTRACAVITARY 
AND SUPERFICIAL APPLICATIONS 

(a) Accountability", storage and transit 
( 1 ) Exc e pt as oth e rwis e sp e cifically authoriz e d by th e 



410 



yORTH CAROLINA REGISTER 



August 14, 1998 



13:4 



PROPOSED RULES 



IIIWUIIMII.JL ■ini'^iJJlJIJ.jm llll^iH III! 1^ 






ag e ncy — eaeh Each licensee shall provide 
accountability of sealed sources and shall keep a 
record of the issue and return of all sealed sources. A 
physical inventory shall be made at least every six 
months and a written record of the inventory 
maintained. 
(2) When not in use, sealed sources and applicators 
containing sealed sources shall be kept in a protective 
enclosure of such material and wall thickness as 
necessary to assure compliance with the provisions of 
Rules . 1 604, . 1 609 and . 1 6 1 1 of this Chapter. 

(b) Testing sealed sources for leakage and contamination 

( 1 ) All sealed sources with a half-life greater than 30 days 
and in any form other than gas shall be tested for 
leakage and contamination prior to initial use and at 
intervals not to exceed six months. If there is reason 
to suspect that a sealed source might have been 
damaged, or might be leaking, it shall be tested for 
leakage before further use. 

(2) Leak tests shall be capable of detecting the presence 
of 0.005 microcurie of radioactive material on the test 
sample, or in the case of radium, the escape of radon 
at rate of 0.001 microcurie per 24 hours. Any test 
conducted pursuant to Subparagraph {b)(l) of this 
Rule which reveals the presence of 0.005 microcurie 
or more of removable contamination or, in the case of 
radium, the escape of radon at the rate of 0.001 
microcurie or more per 24 hours shall be considered 
evidence that the sealed source is leaking. The 
licensee shall immediately withdraw the source from 
use and shall cause it to be decontaminated and 
repaired or to be disposed of in accordance with 
applicable provisions of Section .1600 of this 
Chapter. A report describing the sealed sources 
involved, the test results and the corrective action 
taken shall be submitted in writing to the agency at the 
address stated in Rule .0111 of this Chapter within 
five days after the test. 

(3) Leak test results shall be recorded in units of 
microcuries and maintained for inspection by the 
agency. 

(c) Radiation surveys 

(1) The maximum radiation level at a distance of one 
meter from the patient in whom brachvtherapy sources 
have been inserted shall be determined by 
measurement or calculation. This radiation level shall 
be entered on the patient's chart and other signs as 
required in Paragraph (d) of this Rule. 

(2) The radiation surveying in Paragraph (c) of this Rule 
or a special survey shall be performed and shall 
include measurements necessary to comply with the 
following requirements: 

(A) The therapeutic use of sealed sources shall not 
create radiation levels in areas occupied by 
patients not undergoing radiation therapy 
which would result in an accumulated dose in 
excess of 125 millirem if a patient were 
continuously present during the entire 



treatment period. 

(B) The licensee shall maintain a record of this 
survey and the calculation which demonstrates 
compliance with Subparagraph (c){ 1 ) of this 
Rule. 

(C) The licensee shall select rooms for 
hospitalization of these sealed source therapy 
patients in a manner so as to minimize 
radiation exposure of other patients, hospital 
staff, visitors and the public, especially those 
who are under 1 8 years of age or who are 
pregnant females. 

(D) This Rule does not relieve the licensee of 
responsibility to monitor or limit occupational 
radiation exposure for the licensee's staff as 
provided in Section .1600 of this Chapter. 

(^^ Th e lic e ns ee shall conduct a survey and a source 

count — en — aH — pati e nts — tr e ated — with — cobalt 60, 
c e sium 137, iridium 192, or radium 226 implants to 
e nsur e that all implants hav e b ee n removed prior to 
r e l e a se of th e pati e nt from th e hospital. Th e r e sults of 
th e s e surv e ys s hall b e r e cord e d and maintain e d for 
insp e ction by th e ag e ncy for two y e ars from the time 
th e implant s ar e r e mov e d. 

(3) Immediately after implanting sources in an individual 
the licensee shall make a radiation survey of the 
individual and the area of use to confirm that no 
source has been misplaced. The licensee shall make a 
record of each survey. 

(4) Immediately after removing the last temporary implant 
source from an individual, the licensee shall make a 
radiation survey of the individual with a radiation 
detection survey instrument to confirm that all sources 
have been removed. The licensee may not release 
from confinement for medical care an individual 
treated by temporary implant until all sources have 
been removed. 

(d) A licensee shall maintain accountability for all 
brachvtherapy sources in storage or in use. After removing 
sources from an individual, a licensee shall return brachvtherapy 
sources to the storage area. A licensee shall ensure that all 
sources taken from the storage area have been returned, and shall 
make a record of the source accountability and retain the record 
for three years. 

(e) For temporary implants, the record shall include: 

(1) the number and activity of sources removed from 
storage; 

(2) the date the sources were removed from storage; 

(3) the number and activity of sources returned to storage; 
and 

(4) the date the sources were returned to storage. 

(f) For permanent implants, the record shall include: 

(1) the number and activity of sources removed from 
storage; 
the date the sources were removed from storage; 



t2J 
15} 



the number and activity of sources returned to storage; 
the date the sources were returned to storage; and 
the number and activity of sources permanently 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



411 



PROPOSED RULES 



implanted in the individual. 
fd){g} Signs and records 

( 1 ) In addition to tiie requirements of Rule . 1 624 of this 
Chapter, the bed, cubicle, or room of the hospital 
brachytherapy patient shall be marked with a sign 
indicating the presence of brachytheraps sources. 
This sign shall incorporate the radiation symbol and 
specify the radionuclide, activity, date, and the 
individual(s) to contact for radiation safety 
instructions. The sign is not required provided the 
exception in Rule .1625 of this Chapter is satisfied. 

(2) The following information shall be included in the 
patient's chart: 

(A) the radionuclide administered, number of 
sources, activity in millicuries and time and 
date of administration: 

(B) the exposure rate at one meter, the time the 
determination was made, and by whom; 

(C) the radiation symbol: and 

(D) the precautionary instructions necessary to 
assure that the exposure of individuals does not 
exceed that permitted in Paragraph (c) of this 
Rule. 

Authority G.S. 104E-7: 104E-12(a). 

.0703 TELETHERAPY 

(a) Any licensee authorized under Rule .0322 of this Chapter 
to use teletherapy units for treating humans shall cause full 
calibration measurements to be performed on each teletherapy 
unit. 

( 1 ) Such measurement shall be done at all of the 
following times: 

(A) prior to the first use of the unit for treating 
humans; 

(B) prior to treating humans whenever: 

(i) spot-check measurements indicate that 
the output value differs by more than 
five percent from the value obtained at 
the last full calibration corrected 
mathematically for physical decay, or 

(ii) following replacement of the radiation 
source or following reinstallation of the 
teletherapy unit in a new location, or 

(iii) following any repair of the teletherapy 
unit that includes removal of the source 
or major repair of the components 
associated with the source exposure 
assembly; and 

(C) at intervals not exceeding one year. 

(2) Full calibration measurements required by 
Subparagraph (a)(1) of this Rule shall include 
determination of: 

(A) the exposure rate or dose rate to an accuracy 
within plus or minus three percent for the range 
of field sizes and for the range of distances (or 
for the axis distance) used in radiation therapy; 

(B) the congruence beUveen the radiation field and 



the field indicated by the light beam localizing 
device; 

(C) the uniformity of the radiation field and its 
dependence upon the orientation of the useful 
beam; 

(D) timer accuracy; and 

(E) the accuracy of all distance-measuring devices 
used for treating humans. 

(3) Full calibration measurements shall be made in 
accordance with the procedures recommended by the 
Scientific Committee on Radiation Dosimetry of the 
American Association of Physicists in Medicine 
(Physics in Medicine and Biology. Vol. 16. No. 3. 
1971, pp. 379-396). 

(4) The exposure rate or dose rate values determined in 
Part (a)(2)(A) of this Rule shall be corrected 
mathematically for physical decay for intervals not 
exceeding one month. 

(5) Full calibration measurements required by 
Subparagraph (a)( 1 ) of this Rule and physical decay 
corrections required by Subparagraph (a)(4) of this 
Rule shall be performed by an expert qualified by 
training and experience in accordance with 
Subparagraph (d)( 1 ) of this Rule. 

(b) Any licensee authorized under Rule .0322 of this Chapter 
to use teletherapy units for treating humans shall cause 
spot-check measurements to be performed on each teletherapy 
unit at intervals not exceeding one month. 

( 1 ) Required spot-check measurements shall include 
determination of: 

(A) timer accuracy; 

(B) the congruence between the radiation field and 
the field indicated by the light beam localizing 
device; 

(C) the accuracy of all distance-measuring devices 
used for treating humans; 

(D) the exposure rate, dose rate, or a quantity 
related in a known manner to these rates for 
one typical set of operating conditions; and 

(E) the difference between the measurement made 
in Part (b)(1)(D) of this Rule and the 
anticipated output, expressed as a percentage 
of the anticipated output (i.e.. the value 
obtained at last full calibration corrected 
mathematically for phy sical decay). 

(2) Required spot-check measurements shall be 
performed in accordance with procedures established 
by an expert qualified by training and experience in 
accordance with Paragraph (d) of this Rule. 

(c) Any licensee responsible for the performance of full 
calibration or spot-check measurements shall be required to 
calibrate the instruments used in making such determinations. 

( 1 ) Full calibration measurements required by Paragraph 
(a) of this Rule shall be performed using a dosimetry 
system that has been calibrated by the National 
Bureau of Standards or by a Regional Calibration 
Laboratory accredited by the American Association of 
Physicists in Medicine. The dosimetry system shall 



412 



SORTH CAROLISA REGISTER 



August 14, 



1998 



13:4 



PROPOSED RULES 



UMMLWIMgwmuju.'UXMUwj. J^'^^^^iiBTl^MT^!i;■^^l^n; 






have been calibrated within the previous two years 

and after any servicing that may have affected system 

cahbration. 

(2) Spot-check measurements required by Paragraph (b) 

of this Rule shall be performed using a dosimetry 

system that has been calibrated in accordance with 

Subparagraph (c)( 1 ) of this Rule. Alternatively, a 

dosimetry system used solely for spot-check 

measurements may be calibrated by direct 

intercomparison with a system that has been 

calibrated in accordance with Subparagraph (c)(1) of 

this Rule. This alternative calibration method shall 

have been performed within the previous one year and 

after each servicing that may have affected system 

calibration. Dosimetry systems calibrated by this 

alternative method shall not be used for full 

calibration measurements. 

(d) The licensee shall determine if a person is an expert 

qualified by training and experience to calibrate a teletherapy 

unit and establish procedures for and review the results of 

spot-check measurements. 

(1) The licensee shall determine that the expert is 
qualified by his: 

(A) being certified by the American Board of 
Radiology in therapeutic radiological physics, 
radiological physics, roentgen-ray and 
gamma-ray physics, or x-ray and radium 
physics: or 

(B) having the following minimum training and 
experience: 

(i) a master's or doctor's degree in physics, 
biophysics, radiological physics or 
health physics; 
(ii) one year of full-time training in 

therapeutic radiological physics; and 
(iii) one year of full-time experience in a 
radiotherapy facility including personal 
calibration and spot check of at least one 
teletherapy unit. 

(2) The licensee who has his teletherapy units calibrated 
by persons who do not meet the criteria for minimum 
training and experience stated in Part (d)( 1 )(B) of this 
Rule may request a license amendment excepting 
them from these requirements. 

(A) Such request shall include: 

(i) the name of the proposed qualified 

expert; 
(ii) a description of his training and 
experience including information similar 
to that specified in Part (d){ 1 )(B) of this 
Rule; 
(iii) reports of at least one calibration and 
spot-check program based on 
measurements personally made by the 
proposed expert within the last ten 
years; and 
(iv) written endorsement of the technical 
qualifications of the proposed expert 



from personal knowledge by a physicist 

certified by the American Board of 

Radiology in one of the specialties listed 

in Part (d)(1)(A) of this Rule. 

(B) — The — individual's — qualifications — w+H — be 

evaluat e d — by — the — Divi s ion — ef — Radiation 

Prot e ction, North Carolina D e partment of 

Environm e nt, H e alth, and Natural Resourc e s. 

(e) The licensee shall maintain, for inspection by the agency, 
records of the measurements, tests, corrective actions, and 
instrument calibrations made under Paragraphs (a), (b), and (c) 
of this Rule, and records of the licensee's evaluation of the 
qualified expert's training and experience made under Paragraph 
(d) of this Rule for the following periods of time: 

(1) Records of the full calibration measurements under 
Paragraph (a) of this Rule and the calibration of the 
insfruments used to make these measurements under 
Paragraph (c) of this Rule shall be preserved for five 
years after completion of the calibration. 

(2) Records of the spot-check measurements and 
corrective actions under Paragraph (b) of this Rule 
and the calibration of instruments used to make 
spot-check measurements under Paragraph (c) of this 
Rule shall be preserved for two years after completion 
of the spot-check measurements and corrective 
actions. 

(3) Records of the licensee's evaluation of the qualified 
expert's training and experience under Paragraph (d) 
of this Rule shall be preserved for five years after the 
qualified expert's last performance of a fiall calibration 
on the licensee's teletherapy unit. 

(f) Each teletherapy room shall be equipped with a radiation 
monitoring device which continuously monitors the teletherapy 
beam condition and is equipped with a back-up battery power 
supply for emergency operation. 

( 1 ) This device shall energize a visible signal to make the 
operator continuously aware of teletherapy beam 
conditions in order that appropriate emergency 
procedures may be instituted to prevent unnecessary 
radiation exposure. 

(2) Operating procedures shall be modified to require 
daily operational testing of the installed radiation 
monitor. 

(3) If a radiation monitor is inoperable for any reason, 
any person entering the teletherapy room shall use a 
properly operating portable radiation survey 
instrument or a personal dosimeter with an audible 
alarm to monitor for any malfunction of the source 
exposure mechanism which may have resulted in an 
exposed or partially exposed source. 

(4) Survey instruments or dosimeters shall be tested daily 
before use. 

(g) The licensee shall cause each teletherapy unit used to treat 
humans to be fully inspected and serviced during source 
replacement or at intervals not to exceed five years, whichever 
comes first, to assure proper functioning of the source exposure 
mechanism. 

(h) Inspection and servicing of the teletherapy unit shall be 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



413 



PROPOSED RULES 



performed b\ persons specificall\ authorized to perform such 
services b\ a specific license issued b\' the agenc\. the U.S. 
Nuclear Reguiaton. Commission or an agreement state. 

ijj A licensee shall post safety instructions at the teletherap\' 
unit console. To satisl\ this requirement, these instructions shall 
inform the operator of: 

( 1) The procedures to be followed to ensure that onlv the 
indisidual for whom treatment is planned is in the 
treatment room before turning the primars beam of 
radiation on to begin a treatment or after a door 
interlock interruption: and 

(2) The procedure to be followed, if: 

(A) the operator is unable to turn the primar\' beam 
of radiation off with controls outside the 
treatment room or if anN other abnormal 
operation occurs: and 

(B) the names and telephone numbers of the 
authorized users and radiation safet\ officer to 
be immediateK contacted if the teletherap\ unit 
or console operates abnormalK. 

(jj A licensee shall provide instruction in the topics identified 
in Paragraph Ijj of this Rule to all individuals who operate a 
teletherapy unit. 

(k) A licensee shall retain for three years a record of 
individuals receiving instruction required bv Paragraph (i) of this 
Rule, a description of the instruction, the date of instruction, and 
the name of the individual who gave the instruction. 

ijj A licensee shall control access to the teletherapy room b\ 
a door at each entrance. 

(m) A licensee shall equip each entrance to the teletherapy 
room with an electrical interlock svstem that will: 

( 1) prevent the operator from turning the primary beam of 
radiation on unless each treatment room entrance door 
is closed: 

turn the primary beam of radiation off immediately 
vshen an entrance door is opened: and 
prevent the primary beam of radiation from being 
turned on following an interlock interruption until all 
treatment room entrance doors are closed and the 
beam on-off control is reset at the console, 
(n) A licensee shall equip each entrance to the teletherapy 
room with a beam condition indicator light. 

(o) A licensee shall install in each teletherapy room a 
permanent radiation monitor capable of continuously monitoring 
beam status. 



12} 
01 



(1) A radiation monitor must provide visual notice of a 
teletherapy unit malfunction that results in an exposed 
or partially exposed source, and must be obsersable 
bv an indiv idual entering the teletherapy room. 

(2) A radiation monitor must be equipped wit h a backup 
power supply separate from the pov\ er supply to the 
teletherapy unit. This backup supply may be a battery 
system. 

(3) A radiation monitor shall be checked with a dedicated 
check source for proper operation each day before the 
teletherapy unit js used for treatment of patients or 
human research subjects. 

(4) A licensee shall maintain a record of the check 



required by Subparagraph (o)(3) of this Rule for three 
years. The record shall include: 

(A) the date of the check: 

(B) notation that the monitor indicates when its 
detector is and is not exposed: and 

(C) the initials of the individual who performed the 
check. 

(5) If a radiation monitor is inoperable, the licensee shall 
require any individual entering the teletherapy- room 
to use a survey instrument or audible alarm personal 
dosimeter to monitor for any malfunction of the 
source exposure mechanism that mav result in an 
exposed or partially exposed source. The instrument 
or dosimeter shall be checked with a dedicated check 
source for proper operation at the beginning of each 
day of use. The licensee shall keep a record as 
described in Subparagraph (o)(4) of this Rule. 

(6) A licensee shall promptly repair or replace the 
radiation monitor if it is inoperable. 

Authority- G.S. 104E-'(a)(2). 

SECTION .1000 - NOTICES: INSTRUCTIONS: 
REPORTS AND INSPECTIONS 

.1003 INSTRUCTIONS TO WORKERS 

(a) All individuals who, in the course of emplovrnent. are 
likely to receive in a vear an occupational dose in excess of 100 
millirem ( 1 millisievert) working in or fr e qu e nting anv portion 
of a r es tricted area shall be kept informed of the storage, 
transfer, or use of radioactive material or of radiation in such 
portions of the restricted area: shall be instructed in the health 
protection problems associated with exposure to such radioactive 
material or radiation, in precautions or procedures to minimize 
exposure, and in the purposes and functions of protective 
devices employed: shall be instructed in. and instructed to 
observe, to the extent within the worker's control, the applicable 
prov isions of this Chapter and licenses for the protection of 
personnel from exposures to radiation or radioactive material 
occurring in such areas; shall be instructed of their responsibility 
to report promptly to the licensee or registrant any condition 
which mav lead to or cause a violation of rules in this Chapter 
and licenses or unnecessary- exposure to radiation or radioactive 
material: shall be instructed in the appropriate response to 
warnings made in the event of anv unusual occurrence or 
malfunction that may- involve exposure to radiation or 
radioactive material: and shall be advised as to the radiation 
exposure reports which workers mav request pursuant to Rule 
.1004 of this Section. The extent of these instructions shall be 
commensurate with potential radiological health protection 
problems in the restricted area. 

(b) In determining those individuals subject to the 
requirements of Paragraph (a) of this Rule, licensees or 
registrants shall take into consideration assigned activities dtiring 
normal and abnormal situations involv ing exposure to all sources 
of radiation and radioactive material which can reasonably be 
expected to occur during the life of the licensed or registered 
facility. The extent of these instructions shall be commensurate 



414 



\ORTH CAROLI.\A REGISTER 



August 14, 1998 



13:4 



■BasHRfsai 



MiuMPiui. ji'H-rmM^, I ii II ^11 1 III I iiiuM 



PROPOSED RULES 



with the potential radiological health protection problems present 
in the workplace. 

Authority G.S. 104E-7; 104E-10; 104E-12. 

SECTION .1600 - STANDARDS FOR 
PROTECTION AGAINST RADIATION 

.1633 TRANSFER FOR DISPOSAL AND 
MANIFESTS 



Waste Manifest and transfer this recorded manifest information 
to the intended consignee in accordance with this Rule and 
Appendix G to 10 CFR 20. 

(c) The manif e st r e quir e d in Paragraph (a) of this Rul e may 
be — shipping pap e rs — us e d to — wteet — Ur&-. — D e partm e nt — ef 
Transportation or U.S. Environm e ntal Prot e ction Agency 
r e gulations or requirem e nt s of th e r e c e iv e r, provided all 
information r e quir e d in Paragraphs (a) and (b) of this Rul e is 
includ e d. 

(c) Each shipment manifest shall include a certification by the 
waste generator as specified in Appendix G to 10 CFR 20. 

(d) Any lic e ns ee who tran s f e r s wast e to a lic e ns e d land wast e 
disposal facility or a licen s ed waste collector s hall comply with 



th e requirements in Subparagraphs (d)(1) through ( 8 ) of thi s 



(a) Th e lic e ns ee shall pr e par e a shipm e nt manif e st which shall 
accompany each s hipm e nt of wast e and which shall includ e th e 
following information: 

(a) The requirements of this Rule and Appendix G to 10 CFR 
20. incorporated by reference in Rule .0117 of this Chapter, are Rul e . — Any lic e ns ee who transf e rs wast e to a licensed wast e 
designed to: 

fH — th e nam e , addr e ss and t e l e phon e numb e r of th e p e rson 

generating th e wast e : 
(1) control transfers of low-level radioactive waste by any 
waste generator, waste collector, or waste processor 
licensee, as defined in Appendix G to 10 CFR 20. 
who ships low-level waste either directly, or indirectly 
through a waste collector or waste processor, to a 
licensed low-level waste disposal facility, as defined 
in Rule .1202 of this Chapter: 



(3^ — th e nam e , addr e ss and t e l e phon e numb e r of th e p e rson 

transporting th e wa s t e to th e wast e disposal facility; 
(2) establish a manifest tracking system: and 
(4) — as compl e t e a — s tat e m e nt — as — practicabl e of th e 

following information: 

(A) — a physical d e scription of th e wa s t e , 

(6) — th e wast e volum e . 

(€) — th e radionuclid e id e ntity and quantity. 

(©) — th e total quantity of radioactivity. 

(E) — the — total — quantity — of th e — radionuclid e s: 
hydrog e n 3. carbon M. t e chn e tium 99 and 
iodin e- 129, and 

(F) — th e principal ch e mical form: 

th e solidification ag e nt, if any: 



f#) if th e wast e contains mor e than 0. 1 p e rcent chelating 

ag e nts by w e ight, th e id e ntity and e stimat e d weight 
p e rc e nt of th e ch e lating ag e nts: and 

(6) — a cl e ar stat e m e nt of th e wast e class, if d e termined to 
b e e ith e r Class A. Class B or Class C wast e pur s uant 



to th e provisions of Rul e .1650 of this Section. 



proc e ssor who tr e ats or r e packag e s wast e shall comply with the 
r e quir e m e nts in Subparagraphs (d)(i) through ( 8 ) of this Rule. 
Th e lic e ns ee shall: 

(4^ — pr e par e all wast e s so that th e wast e is classified in 
accordanc e with th e provi s ions of Rul e .1650 of this 
S e ction — and — meets — the — wast e — charact e ristic 
r e quir e m e nts in Rul e .1651 of thi s S e ction: 

(3) lab e l e ach packag e of wa s t e a s Clas s A. Class B or 

Class C a s d e t e rmin e d in accordanc e with th e 
provi s ions of Rul e .1650 of this S e ction: 
(3^ — conduct — a — quality — control — program — te — assur e 
complianc e with th e provi s ion s of Rul es .1650 and 
.1651 of thi s S e ction and to includ e manag e m e nt 
e valuation of audits: 

(4) pr e par e shipping manif e sts in accordanc e with th e 

provisions of Paragraphs (a) and (b) of this Rul e ; 

{S^ at th e tim e of shipm e nt, fonvard a copy of th e 

manif e st to th e intend e d r e cipi e nt; or, at th e tim e th e 
wast e is collect e d, hav e th e coll e ctor aclcnowl e dg e 
r e c e ipt by s igning th e lic e nse e 's copy of the manif e st 
and provid e a copy of th e manifest to th e collector; 

(6) includ e on e copy of the manif e st wiih th e shipm e nt; 

f?) — r e tain a copy of th e manif es t, with documentation of 
aclcnowl e dg e m e nt of r e c e ipt, a s th e r e cord of transfer 
of lic e n se d radioactiv e mat e rial a s r e quir e d in Rules 
.0 1 1 5 and . 1 6 4 2 of thi s Chapt e r: and 
(8) — conduct — an — inv es tigation — m — accordanc e — with 
Paragraph (g) of thi s Rul e for any s hipm e nts or any 
part of a s hipm e nt for which notification of receipt 
ha s not b ee n r e c e iv e d within 20 day s aft e r transf e r. 
(d) Each person involved in the transfer for disposal and 
disposal of waste, including the waste generator, waste collector, 
waste processor, and disposal facility operator, shall comply 
with the requirements specified in this Rule and Appendix G to 
10 CFR 20. 



(3) supplement existing requirements concerning 
transfers and recordkeeping for those wastes. 

(fe^ — In e ach manif es t th e wast e g e n e rator s hall includ e a 
c e rtification that th e transport e d mat e rials ar e prop e rly cla s sifi e d, 
d e scribed, packag e d, mark e d, and labeled and arc in proper 

condition — for tran s portation — according to — th e applicable (e) Any wast e coll e ctor lic e ns ee who handl e s only 

r e gulations of the U.S. D e partm e nt of Transportation and the pr e packag e d wast e shall: 
ag e ncy. — An authoriz e d r e pr e s e ntativ e of th e waste generator 
shall sign and dat e th e manifest. 

(b) Any licensee shipping radioactive waste intended for 
ultimate disposal at a licensed land disposal facility shall 
document the information required on the U.S. Nuclear 
Regulatory Commission's Uniform Low-Level Radioactive 



fH — aclcnowl e dg e r e c e ipt of th e waste from th e g e n e rator 
within on e w ee k of r e ceipt by r e turning a s ign e d copy 
of th e manif e st to the gen e rator; 

(3) pr e par e — a — new — manif e st — which — shaH — r e fl e ct 

con s olidat e d shipments, s e rv e as a li s ting or ind e x for 
th e d e tail e d gen e rator manif e sts, and include copi e s of 



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415 



PROPOSED RULES 



th e g e nerator monif e Gts: or pr e par e a n e w manif e st 

without attaching th e g e n e rator manif es ts, provid e d 

th e n e w manif e st contain s for e ach paclcag e th e 

information specifi e d in Paragraph (a) of this Rul e : 
f3^ c e rtify' that nothing has b ee n don e to th e wast e which 

would invalidat e th e g e n e rator' s c e rtification: 
{4) forward a cop\ of th e n e vs manif e st to th e land 

disposal facility operator at th e tim e of shipm e nt: 
f#^ includ e th e n e w manifest \sith the shipment to th e 

disposal sit e : 
(4) retain a cop\ of th e manif e st \\\x\\ docum e ntation of 

acknovsl e dg e m e nt of r e c e ipt a s th e r e cord of transf e r 

of lic e nsed radioactiv e mat e rial a s requir e d in Rul es 

.01 15 — and — .16 ' 12 — of this — Chapt e r. — aftd — r e tain 

information from gen e rator manif e sts until disposition 

i s authoriz e d b> the agenc\ : and 
f?^ conduct — an — in\ e stigation — m — accordanc e — w4th 

Paragraph (g) of thi s Rul e for an\ shipm e nt s or an\ 

part of a shipm e nt for which notification of r e c e ipt 

has not boon receiv e d x' . ithin 20 da\ s aft e r transf e r. 

(e) Reports and notifications required to be made to the 
nearest regional administrator by Appendix G to J_0 CFR 20 
shall, instead, be made to the agenc\. 

(f) An> lic e n se d waste proc e ssor who tr e ats or r e packag e s Authority G.S. 104E-'ta)(2).(a}(3>: 104E-12(a). 
wast e s shall: 

f+4 acknowl e dg e r e c e ipt of th e xi i ast e from th e g e n e rator 

within ono w ee k of r e c e ipt b\ r e turning a sign e d cop\ 

of th e manif e st to the gen e rator: 
{¥i — pr e par e a n e w manif e st that moots tho r e quir e m e nts of 

Paragraphs (a), (b) and (c) of this Rul e . th e r e b> 

r e fl e cting th e fact that the proc e ssor is r e sponsibl e for 

th e wa s t e : 
{^ pr e par e all wast e s so that th e wast e is clas s ifi e d in 

accordance with th e provisions of Rul e .1650 of this 



fi^) acknov i l e dg e r e ceipt of th e waste within on e w ee k of 

r e c e ipt b> r e turning a sign e d copy of th e manif e st or 
e quival e nt docum e ntation to th e shipper, where such 
s hipper is th e lic e ns ee who last possess e d th e waste 
and tran s f e rr e d th e wast e to th e operator: 

(3^ iftdk at e on th e r e turn e d cop\ of th e manif e st or 

e quival e nt docum e ntation in Subparagraph (g)(1) of 
this Rul e an>' discr e panci e s b e tx^ iee n mat e rial s list e d 
on th e manif e st and materials r e ceived: 

(^■) maintain copies of all — completed manif e st s or 

e quival e nt docum e ntation until th e ag e ncy authoriz es 
th e ir disposition: and 

{A) notifi th e shipp e r ( e .g.. th e g e n e rator, th e coll e ctor, or 

proc e ssor) and th e ag e ncy wh e n an\ s hipm e nt or part 

of a s hipm e nt has not arriv e d within 60 da\s aft e r the 

advanc e manif e st was r e c e iv e d. 

(h) If the shipp e r do e s not r e c e iv e a notification of receipt for 

an> shipm e nt or an\ part of a shipment within 20 da\'s aft e r 

transf e r, th e shipp e r s hall conduct an inv e stigation, to includ e a 

trac e of th e shipm e nt. Th e s hipp e r and an\ oth e r lic e ns ee who 

conducts a trac e inv e stigation s hall fil e a writt e n r e port w ith th e 

agencx within two w ee lcs of th e compl e tion of th e investigation. 



.1635 GENERAL PROVISIONS FOR RECORDS 

(a) Each licensee or registrant shall use the units: curie, rad 
and rem. including multiples and subdivisions thereof, and shall 
clearK indicate the units of all quantities on records required b> 
this Section. 

(b) Notwithstanding the requirements of Paragraph (a) of this 
Rule, when recording information on shipping manifests, as 
required by Rule .1633 of this Section and .Appendix G to 10 
CFR 20. information shall be recorded in the International 

S e ction — and — m ee ts — the — wast e — characteristics S\stem of Units (SI) or SI and units as specified in Paragraph (a) 



r e quir e m e nt s in Rul e .1651 of this S e ction: 

f4-) lab e l e ach packag e of wast e as Class A. Class B or 

Class C as d e t e rmin e d in accordanc e with th e 
provisions of Rul e s .1650 and .1652 of this S e ction: 

{%^ conduct — a — qualit> — control — program — te — assur e 

complianc e with th e provisions of P^ules .1650 and 
.1651 of this S e ction and to includ e manag e ment 
e valuation of audit s : 



(44- 



jf-the 



at th e time of shipm e nt, forward a copv ot tn e 
manif e st to th e int e nd e d r e cipient: or. at the tim e th e 
wast e is coll e ct e d, hav e th e coll e ctor acknowledg e 
r e c e ipt bv signing th e lic e ns ee 's copv of th e manif e st 
and provid e a copv of th e manif e st to th e coll e ctor: 

f74 includ e tho new manif e st with th e shipm e nt: 

f84 r e tain a copv of th e manif es t, with docum e ntation of 

acknowl e dg e m e nt of r e c e ipt, as th e r e cord of transf e r 
of lic e n se d radioactiv e mat e rial as r e quir e d in Rul es 
.0115 and .1612 of this Chapt e r: 

^ conduct — an — inv e stigation — m — accordanc e — with 

Paragraph (g) of this Rule for anv shipm e nts or anv 
part of a shipm e nt for v i hich notification of r e ceipt 
has not been receiv e d vsithin 20 davs aft e r tran s f e r, 
(g) Anv radioactiv e v - ast e dispo s al facilit> op e rator shall: 



of this Rule. 

f^c) The licensee or registrant shall make a clear distinction 
between the quantities entered on the records required by this 
Section (e.g.. total effective dose equivalent, shallow-dose 
equivalent, eye dose equivalent, deep-dose equivalent, 
committed effective dose equivalent). 

feXd) The discontinuance or curtailment of activities does not 
relieve the licensee or registrant of responsibilitv for retaining all 
records required b\' the rules in this Section. A lic e ns ee or 
r e gistrant, mav. howovor r e qu e st th e ag e ncv to accept such 
records. — If th e ag e ncv accepts such r e cords, th e lic e ns ee or 
registrant is r e liev e d of subs e qu e nt r e spon s ibilitv onlv in r e sp e ct 
to th e ir prosop . ation as r e quir e d bv the rules in this S e ction. 

Authority G.S. 104E-'(ai<2i: 104E-12(a}. 

.1647 REPORTS OF R.A.DI.\TION 
EXCEEDING THE LIMITS 

(a) In addition to the notification required b\ Rule .1646 of 
this Section, each licensee or registrant shall submit a wrinen 
report w ithin 30 davs after learning of anv of the following 
occurrences: 

( 1 ) anv incident for which notification is required bv Rule 



416 



.\ORTH C.4R0LI.\A REGISTER 



August 14, 1998 



13:4 



HIlllJJMnAWUlUBfyiUTZ 



PROPOSED RULES 



(2) 



(3) 



.1646 of this Section; 

doses in excess of any of the following: 

(A) the occupational dose limits for adults in Rule 
.1604 of this Section; 

(B) the occupational dose limits for a minor in Rule 
.1609 of this Section; 

(C) the limits for an embryo/fetus of a declared 
pregnant woman in Rule .1610 of this Section; 

(D) the limits for an individual member of the 
public in Rule .1611 of this Section; 

(E) any applicable limit in the license; or 

(F) The ALARA constraints for air emissions 
established in Rule .1603 of this Section; 

levels of radiation or concentrations of radioactive 
material in: 

(A) a restricted area in excess of any applicable 
limit in the license; or 

(B) an unrestricted area in excess of 1 times any 
applicable limit set forth in this Section or in 
the license, whether or not involving exposure 
of any individual in excess of the limits in Rule 
.1611 of this Section. 

(b) Each report required by Paragraph (a) of this Rule shall 
describe the extent of exposure of individuals to radiation and 
radioactive material, including, as appropriate: 

(1) estimates of each individual's dose: 

(2) the levels of radiation and concentrations of 
radioactive material involved; 

(3) the cause of the elevated exposures, dose rates, or 
concentrations; and 

(4) corrective steps taken or planned to ensure against a 
recurrence, including the schedule for achieving 
conformance with applicable limits, ALARA 
constraints, generally applicable environmental 
standards, and associated license conditions. 

(c) Each report filed pursuant to Paragraph (a) of this Rule 
shall include for each occupationally overexposed individual: the 
name, social security account number, and date of birth. With 
respect to the limit for the embryo/fetus required by Rule .1610 
of this Section, the identifying information shall be that of the 
declared pregnant woman. The report shall be prepared so that 
this information is stated in a separate and detachable part of the 
report. 

(d) Reports made by licensees or registrants in response to the 
requirements of this Rule shall be addressed to the agency as 
specified in Rule .0111 of this Chapter. 

(e) Any reports made by licensees or registrants in response 
to the requirements of this Rule shall also be provided to the 
exposed individual. The copy submitted to the exposed 
individual shall be transmitted at a time no later than the 
transmittal to the agency. 

Authority G.S. 104E-7(a)(2): W4E-12(a). 

.1653 RADIOLOGICAL REQUIREMENTS 
FOR LICENSE TERMINATION 

(a) General provisions and scope: 
(1) The requirements in thjs Rule apply to the 



decommissioning of facilities licensed under the rules 
of this Chapter. For low-level radioactive waste 
disposal facilities licensed under Section .1200 of this 
Chapter, the requirements apply only to ancillary 
surface facilities that support radioactive waste 
disposal facilities. 

(2) The requirements in this Rule do not apply to sites 
which: 

(A) have been decommissioned prior to the 
effective date of this Rule in accordance with 
criteria approved by the agency; or 

(B) have previously submitted and received agency 
approval for a license termination plan or for a 
decommissioning plan. 

(3) After a site has been decommissioned and the license 
terminated in accordance with the requirements set 
forth in this Rule, the agency may require additional 
cleanup only if based on new information, the agency 
determines that the requirements of this Rule were not 
met and residual radioactivity remaining at the site 
could result in a significant threat to the public health 
and safety. 

(4) When calculating Total Effective Dose Equivalent 
(TEDEj to the average member of the critical group, 
the licensee shall determine the peak annual TEDE 
expected within the first 1,000 years after 
decommissioning. 

(b) Radiological criteria for unrestricted use of a site shall be 
considered acceptable for unrestricted use if the residual 
radioactivity that is distinguishable from background 
radioactivity results in a TEDE to an average member of the 
critical group that does not exceed 25 millirem (0.25 millisievert) 
per year, including that from groundwater sources of drinking 
water, and the residual radioactivity has been reduced to levels 
that are as low as reasonably achievable (ALARA). 
Determination of the levels, which are ALARA, may take into 
account consideration of detriments, such as deaths from 
transportation accidents, expected to potentially result from 
decontamination and waste disposal. 

(c) A sjte shall be considered acceptable for license 
termination under restricted conditions if: 

( 1) the licensee can demonstrate that further reductions in 
residual radioactivity necessary to comply with the 
provisions of Paragraph (b) of this Rule would result 
in net public or environmental harm or were not being 
made because the residual levels associated with 
restricted conditions are ALARA. Determination of 
the levels which are ALARA may take into account 
consideration of detriments, such as traffic accidents, 
expected to result fi'om decontamination and waste 
disposal; 

the licensee has made provisions for legally 
enforceable institutional controls that provide 
reasonable assurance that the TEDE from residual 
radioactivity distinguishable from background 
radioactivity, to the average member of the critical 
group, will not exceed 25 millirem (0.25 millisievert) 
per year; 



(2} 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



417 



PROPOSED RULES 



(3) the licensee has provided sufficient financial 
assurance to enable an independent third parrs; 
including a governmental custodian of a site, to 
assume and carry out responsibilities for anv 
necessary control and maintenance of the site. 
Acceptable financial assurance mechanisms to meet 
the requirements of Subparagraph (c)(3) of this Rule 
are described in Rule .0354 of this Chapter. 

(4) the licensee has submitted to the agency a 
decommissioning plan or license termination plan, as 
described in Rule .033Q of this Chapter, indicating the 
licensee's intent to decommission in accordance u ith 
the requirements of this Chapter, and specifying that 
the licensee intends to decommission by restricting 
use of the site: 
the licensee has documented in the license termination 



effect, there js reasonable assurance that the TEDE 
from residual radioactivity distinguishable from 
background radioactivity to the average member of 
the critical group is as low as reasonably achievable 
and would not exceed either: 



t5J 



L6J 



plan or decommissioning plan how the advice of 
individuals and institutions m the community who 
ma\ be affected by the decommissioning has been 
sought and incorporated, as appropriate, following 
analysis of that advice: 

(A) licensees proposing to decommission by 
restricting use of the site shall have sought 
advice from such affected parties regarding the 
following matters concerning the proposed 
decommissioning: 

(i) whether provisions for institutional 
controls proposed by the licensee will 
provide reasonable assurance that the 
TEDE from residual radioactivity' 
distinguishable from background 
radioactivity to tfie average member of 
the critical group will not exceed 25 
millirem (0.25 millisievert) TEDE per 
year, will be enforceable and will not 
impose undue burdens on the 
community or other affected parties: and 

(ii) whether the licensee has provided 
sufficient financial assurance to enable 
an independent third party, including a 
governmental custodian of a site, to 
assume and carr v out responsibilities for 
any necessary control and maintenance 
of the site. 

(B) the licensee has provided for: 

(i) participation by representatives of a 
broad cross-section of community 
interests who may be affected by the 
decommissioning: 
(ii) an opportunity for a comprehensive, 
collective discussion of the issues by the 
participants represented: and 
(iii) a publicly available summary of the 
results of all such discussions, and the 
extent of agreement and disagreement 
among the participants on the issues, 
residual radioactiv in at the site has been reduced so 
that if the institutional controls were no longer in 



(A) 1 00 millirem ( 1 millisievert) per year: or 

(B) 500 millirem (5 millisievert) per year provided 
the licensee: 

(]} demonstrates that further reductions in 
residual radioactivity necessary to 
comply with the 100 millirem per year 
( I millisievert per year) value described 
in Part (c)(6)(A) of this Rule, are not 
technically achievable, would be 
prohibitively expensive, or would result 
in net public or environmental harm: 
(ii) makes provisions for durable 

institutional controls: or 
(iii) provides sufficient financial assurance 
to enable a responsible government 
entity or independent third party, 
including a governmental custodian of a 
site, both to carry out periodic rechecks 
of the site no less frequently than every 
five years to assure that the institutional 
controls remain in place as necessary to 
meet the requirements of Subparagraph 
(c)(2) of this Rule and to assume and 
carry out responsibilities for any 
necessary control and maintenance of 
those controls, 
(d) Alternate criteria for license termination: 
(1) The agency may terminate a license using alternate 
criteria greater than the dose requirements of 
Paragraph (b). Subparagraph (c)(2). and Subpart 
(c)(5)(A)(i) of this Rule, if the licensee: 

(A) provides assurance that public health and 
safety would continue to be protected, and that 
it is unlikely that the dose from aij man-made 
sources combined, other than medical, would 
be more than 100 millirem TEDE per year 0_ 
millisievert per year) limit described in Rule 
■ 1611 of this Section, by submitting an analysis 
of possible sources of exposure: 

(B) has employed, to tlie extent practical, 
restrictions on site use according to the 
provisions of Paragraph (c) of this Rule in 
minimizing exposures at the site: 

(C) reduces doses to ALARA levels, taking into 
consideration detriments such as traffic 
accidents expected to potentially result fi'om 
decontamination and waste disposal: 

(D) has submitted a decommissioning plan or 
license termination plan to ttie agency 
indicating the licensee's intent to decommission 
in accordance with tfie requirements of this 
Chapter and specifying that the licensee 
proposes to decommission by use of alternate 



41H 



yORTH CAROLIXA REGISTER 



Auoust 14, 1998 



13:4 



PROPOSED RULES 



BHHREOBe&aa 






criteria; 

(E) has documented in the decommissioning plan 
or license termination plan how the advice of 
individuals and institutions in the community 
who may be affected by the decommissioning 
has been sought and addressed; and 

(F) in seeking such advice, the licensee has 
provided for: 

tij participation by representatives of a 

broad-cross section of community 

interests who may be affected by the 

decommissioning; 

(ii) an opportunity for a comprehensive. 

collective discussion of the issues by the 

participants represented; and 

(iii) a publicly available summary of the 

results of such discussions, including a 

description of the extent of agreement 

and disagreement among the participants 

on the issues. 

(2) The use of alternate criteria to terminate a license 

requires the consideration of any comments provided 

by any other interested state agencies and any public 

comments submitted pursuant to Paragraph (e) of this 

Rule. 

(e) Upon the receipt of a license termination plan or 

decommissioning plan from the licensee, or a proposal by the 

licensee for release of a site pursuant to Paragraphs (c) and (d) 






m 



m 



of this Rule, or whenever the agency deems such notice to be in 
the public interest, the agency shall notify and solicit comments 
from: 

local governments in the vicinity of the site. 
appropriate state agencies, the U.S. Environmental 
Protection Agency, and any Indian Nation or other 
indigenous people that have treaty or statutory rights 
that could be affected by the decommissioning; and 
publish a notice in a forum, such as local newspapers, 
letters to state or local organizations or other 
appropriate forum that is readily accessible to 
individuals in the vicinity of the site, and solicit 
comments from affected parties. 

Authorities. 104E-7(a)(2l: I04E-I0(b). 



TITLE 21 - OCCUPATIONAL 
LICENSING BOARDS 

CHAPTER 46 - BOARD OF PHARMACY 

Notice is hereby given in accordance with G.S. I50B-21.2 
that the North Carolina Board of Pharmacy intends to 
adopt the rides cited as 21 NCAC 46 . 1612, . 1 706. .2306. .2506 
and amend the rules cited as 21 NC.4C 46 . 1601. . 1 703. . 1809. 
.2304, .2502. .2604, .2609. .2611. Notice of Rule-making 
Proceedings was published in the Register on June 15, 1998. 



Proposed Effective Date: .April 1, 1999 

A Public Hearing will be conducted at 10:00 a.m. on 
September 14, 1998 at the Institute of Pharmacy, Auditorium, 
1 09 Church Street, Chapel Hill, NC 2 7516. 

Reason for Proposed Action: To modify requirements 
regarding the dispensing of prescription drugs by physician 
assistants: to modify requirements for the use of automated data 
processing systems by requiring use of drug interaction 
software; to modify service requirements with regard to 
rehabilitational medical equipment: to modify requirements 
regarding emergency prescription refills; to address late 
renewal fees; to allow for access to pharmacy records by 
parent, spouse, or agent; to address the reporting of and 
documentation of dispensing errors: to regulate pharmacist 
working conditions; to require that a pharmacy must post times 
that a pharmacist is on duty: to correct an incorrect citation in 
21 NCAC 46 . 1601; and to modify' record keeping requirements 
for device and medical equipment permit holders. 

Comment Procedures: Persons wishing to present oral data, 
views or arguments on a proposed rule or rule change, mavfile 
a notice with the Board at least 10 days prior to the public 
hearing at which the person wishes to speak. Comments should 
be limited to 10 minutes. The Board's address is Board of 
Pharmacy PO Box 459. Carrboro, NC 27510-0459. Written 
submission of comments or argument will be accepted at any 
time up to and including September 14, 1998. 

Fiscal Note: These Rules do not affect the expenditures or 
revenues of state or local government funds. These Rules do not 
have a substantial economic impact of at least five million 
dollars ($5, 000, 000) in a 12-month period 

SECTION. 1600 - LICENSES AND PERMITS 

.1601 PHARMACY PERMITS 

(a) Applications for pharmacy permits, whether original or 
renewal, shall be made upon forms provided by the Board. The 
Board shall not issue any original or annual renewal pharmacy 
permit until the Board is satisfied that: 

(1) The pharmacist-manager is sure that at all times 
adequate qualified personnel has been secured by the 
management of the store to properly render 
pharmaceutical service in the manner prescribed by 
law. 

(2) Any and all unlicensed clerks have been instructed 
that they may render pharmaceutical service only as 
an aid to and under the immediate supervision of a 
registered pharmacist. 

(3) The pharmacy posts in a location conspicuous to the 
public the specific hours that a pharmacist is on duty 
in the pharmacy. 

f^(4) The following minimum technical equipment is 
maintained: 
(A) Graduates. Capable of accurately measuring 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



419 



PROPOSED RULES 



(B) 



(C) 

(D) 
(E) 



(F) 
(G) 

(H) 



volumes from 1 ml to at least 500 ml; 
Mortars and pestles: 

(i) one - glass; 
(ii) one ~ "Wedgwood"; 
Stirring Rods. Two different sizes made of 
glass or rubber; 

Ointment slab or suitable substitute; 
Class A prescription or electronic balances and 
appropriate weights, suitable for all required 
weighings, at least one of which must be 
sensitive to six mg; 

Suitable facilities for recording and filing 
prescriptions as required b\ G.S. 90-85.26; 
Spatulas; 

(i) stainless steel, at least three assorted 

sizes; 
(ii) non-metallic, one of an\' size; 
Useable Supplies. Equipped with safet> 
closures where required: 



(i) 



bottles. 1 to 32 fluid 



prescription 
ounces; 
(ii) dropper bottles. 1,2 to 2 fluid ounces; 
(iii) assorted pill and tablet containers; 
(iv) empt> capsules. No. 00 to No. 3; 
(v) powder papers; 
(vi) ointment jars, assorted; 
(vii) prescription labels; 
(viii) all appropriate auxiliarv' labels; 
(I) Heating apparatus; 
(J) Refrigerator; 
(K) Reference librar>. as follows: 



(i) 



(ii) 



(iii) 



(iv) 



(V) 

(vi) 



the latest edition of the United States 
Pharmacopoeia (USP) and National 
Formularj'' and supplements thereto or a 
standard commentary thereon; 
a cop\ of the pharmac> laws of North 
Carolina, including the North Carolina 
Controlled Substances Act and the rules 
adopted pursuant thereto, and the North 
Carolina Pharmacy Practice Act and the 
rules of the Board; 

a cop% of the Federal Controlled 
Substances Act and the regulations 
adopted pursuant thereto; 
a Schedule V controlled substances 
register (where these preparations are 
sold other than on prescriptions); 
a medical dictionary ; 
current editions of generalK accepted 
reference books on the following 
subjects: 

(1) drug interactions. 
(II) clinical pharmacolog>'. 

(III) USP Dispensing Information or 
its equivalent, and 

(IV) if IV admixture services are 
provided, a reference on 
Parenteral Incompatibilities. 



f44(5) The pharmacv is equipped with sanitary' appliances 
including lavatory facilities with hot and cold running 
water; is adequately lighted; and is kept in a clean, 
orderly, and sanitan. condition. 

f^6) All prescription medications are labeled in accordance 
with G.S. 106-134 and 106-134.1. 

(b) In addition to the requirements for issuance and renewal 
of a pharmacy permit imposed by a statute and by other rules of 
the Board, a permit shall not be issued or renewed to any person 
to operate a pharmacv wherein the prescriptions of medical 
practitioners are compounded or dispensed and distributed when 
such distribution is effected by mail and the practitioner- 
pharmacist-patient relationship does not exist, until the Board is 
satisfied that: 

(1) The pharmacv maintains records of prescriptions 
compounded or dispensed and distributed in manner 
that is readily retrievable; 

(2) During the pharmacv 's regular hours of operation but 
not less than six days per week, for a minimum of 
forty hours per week, a toll-free telephone service is 
provided to facilitate communication between patients 
and a pharmacist at the pharmacy who has access to 
the patient's records. TTiis toll-free number must be 
disclosed on the label affixed to each container of 
dispensed drugs; 

(3) The pharmacv' complies with all lawful orders, 
directions, and requests for information from the 
Boards of pharmacv' of all states in which it is 
licensed and all states into which it distributes 
prescription drugs; 

(4) The pharmacy complies with all USP and FDA 
requirements regarding the storage, packaging, and 
shipping of prescription medications. The 
pharmacist-manager and all other pharmacists 
emploN ed in the pharmacies permitted pursuant to this 
Paragraph shall be subject to all Federal and State 
statutes and regulations concerning the dispensing of 
prescription medications including, but not limited to. 
2 1 NCAC 46. 1 80 1 and . 1 805 and 2 1 CFR 1 306.0 1 . 
1306.05. and 1306.21. 

(c) The Board shall not issue an original or renewal permit to 
any person to operate a drugstore or pharmacv as a department 
in or a part of any other business serving the general public 
(except hospitals, nursing homes, and similar institutions subject 
to the provisions of .0300 Section .1400 of this Chapter) unless 
such pharmacy facilit)': 

( 1 ) is ph>'sicall>' separated from such other business; 

(2) is separately identified to the public both as to name 
and anv advertising; 

(3) completes all transactions relati\e to such pharmacv 
v\ ithin the registered facilitv'; and 

(4) meets the same requirements for registration as all 
other pharmacies. 

(d) Permits to operate pharmacies. v\hether original or 
renewal, shall be issued to the pharmacist-manager of such 
pharmacv pursuant to a joint application of the owner and 
pharmacist-manager for the conduct and management of said 
pharmacv. The issuance of said permit shall not be complete 



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and the permit shall not be valid until it has been countersigned 
by the pharmacist-manager as represented in the application. 
The permit so issued is valid only so long as the pharmacist- 
manager to whom it was issued assumes the duties and 
responsibilities of pharmacist-manager. Permits may be reissued 
at any time to a successor pharmacist-manager pursuant to the 
proper amendment of the application for the permit. 

(e) Upon application, the Board may issue and renew separate 
permits for pharmacies operating at one location. Records for 
each permitted pharmacy must be maintained separately. Prior 
to issuance of an original permit, each pharmacy shall submit a 
plan to the Board that shall assure accountability for the actions 
of each pharmacy at the location. 

Authority G.S. 90-85.6: 90-85.21: I50B-11. 

.1612 LATE RENEWAL FEES 

All licenses renewed after March 1 are subject to an additional 
Fifteen dollar (SI 5.00) late renewal fee. All permits renewed 
after March 1 are subject to the original registration fee. 

Authority G.S. 1508-19(5). 

SECTION .1700 - DRUGS DISPENSED BY 
NURSE OR PHYSICIAN'S ASSISTANT 

.1703 DRUGS TO BE DISPENSED 

(a) Such drugs as may be dispensed by the nurse practitioner 
who is authorized to prescribe or dispense drugs shall be limited 
to those drugs in the written standing protocols approved and 
signed by the supervising physician{s), consulting pharmacist, 
and the nurse practitioner and maintained in each practice site. 
The written standing protocols shall include drugs that may be 
prescribed, ordered and implemented by the nurse practitioner. 
All drugs not listed in the written standing protocols which 
might be prescribed by the physician supervising the nurse 
practitioner must be dispensed personally by the prescribing 
physician, by the pharmacist, or by a person acting under the 
supervision of the pharmacist. 

(b) The physician assistant may dispense any and al] drugs that 
the physician assistant is authorized by law to prescribe. Such 
drug s a s may b e disp e ns e d by a physician a s sistant who i s 
authoriz e d to pr e scrib e or disp e nse drug s shall b e limit e d to 
thos e drug s in th e vmtt e n instructions for prescribing drugs from 

th e sup e rvi s ing physician. The written — in s truction s for 

pr e scribing drug s shall include drugs that may b e pr es crib e d, 
ord e r e d and impl e m e nt e d by th e physician a ss i s tant. All drugs 
not li s t e d in th e writt e n instructions for pr es cribing drugs which 
might be pr es crib e d by th e physician s up e rvi s ing th e phy s ician 
assistant mu s t b e disp e ns e d p e rsonally by th e pr es cribing 
physician, by th e pharmacist, or by a person acting und e r th e 
sup e rvision of the pharmacist. 

(c) The pharmacist shall prepare a plan to ensure prop e r 
ord e ring, storing, and packaging of that there are adequate 
amounts of each of the drugs dispensed by a nurse practitioner 
or physician assistant, assistant, and that such drugs are properly 
stored and packaged. All drugs disp e ns e d by a nurse 
practition e r or physician a s sistant shall b e r e view e d by a 



pharmacist on a w ee kly basis for complianc e with r e tro s p e ctiv e 
drug utilization review, for cost e ff e ctiv e us e of pro s cription 
drugs, and to e nsur e optimal drug th e rapy. — Factors to b e 
consid e r e d ar e : 

(+) Need of th e drug, giv e n th e dis e as e s and conditions 

freated; 
(3) Eff e ctiv e n e ss of th e drug, in terms of effici e ncy, 
(a) e ffici e ncy, 
(fe) toxicity, 

(e) pharmacokin e tic prop e rti es , 
(d) bio e quivalenco, if applicabl e , 
{&) pharmaceutical e quival e nc e , if applicabl e , and 
fB th e rap e utic e quival e nc e , if applicable; and 
(54 Risks of: 

(a) Icnown incid e nc e of adv e rs e drug r e actions; 

uliO 

(b) pot e ntial for e rror in pr es cribing or ord e ring 
pr e paration, di s p e n s ing, and administration. 

(d) All drugs dispensed by a nurse practitioner or physician 
assistant must be dispensed from a place holding a current 
pharmacy permit from the Board as required by G.S. 90-85.2 1 . 

(e) The consulting pharmacist shall be available for 
consultation in person, by telephone, or other means of direct 
communication at all times when drugs are dispensed. 

(0 All drugs dispensed by the nurse practitioner or physician 
assistant shall be prepackaged in safety closure containers and 
shall be appropriately prelabeled (including necessary auxiliary 
labels) by the pharmacist with all information required by law 
except the name of the patient and the directions for use. The 
name of the patient and directions for use of the drugs shall be 
placed on the label by the nurse practitioner or physician 
assistant at the time it is delivered to the patient or his agent. 

Authority G.S. 90-18.1: 90-18.2: 90-85.6. 

.1706 RETROSPECTIVE REVIEW 
AND CONSULTATION 

All drugs dispensed by a nurse practitioner or physician 
assistant shall be retrospectively reviewed by a pharmacist on a 
weekly basis. The reviewing pharmacist may advise and consult 
with the dispensing nurse practitioner or physician assistant 
about potential drug therapy concerns which may result from: 

(1 ) therapeutic duplication; 

(2) drug-disease contraindication; 

(3) interactions between or among drugs, including 
serious interactions with prescription or over-the- 
counter drugs; 

(4) incorrect drug dosage or duration of drug treatment; 

(5) interactions between drugs and allergies; and 

(6) clinical abuse or misuse. 

Authority^ G.S. 90-18.1: 90-18.2: 90-85.6. 

SECTION .1800 -PRESCRIPTIONS 

.1809 EMERGENCY PRESCRIPTION REFILLS 

In the event a pharmacist or device and medical equipment 
permit holder receives a request for a prescription refill and the 



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421 



PROPOSED RULES 



pharmacist or permit holder is unable to obtain readily refill 
authorization from the prescriber, the pharmacist or permit 
holder may dispense a one-time emergency refill of up to a 72 
hour s upply of the prescribed medication, provided that: 

(1) The prescription is not for a Schedule 11 controlled 
substance; 

(2) The medication is essentia! to the maintenance of life 
or to the continuation of therapy in a chronic 
condition; 

(3) In the pharmacist's or permit holder's professional 
judgment, the interruption of therapy might 
reasonably produce undesirable health consequences; 

(4) The dispensing pharmacist or permit holder creates a 
written order containing all of the prescription 
information required by Section .2300 of these Rules 
and signs that order; 

(5) The dispensing pharmacist or permit holder notifies 
the prescriber or the prescriber's office of the 
emergencN' dispensing within 72 hours after such 
dispensing. 

Authority G.S. 90-85.6: 90-85.32. 

SECTION .2300 - PRESCRIPTION 
INFORMATION AND RECORDS 

.2304 AUTOMATED DATA PROCESSING 
SYSTEMS 

An automated data processing system ma> be employed as a 
record-keeping system if the following conditions are met; 

(1) The system shall have the capability of producing 
sight-readable documents of all original and refilled 
prescription information. The term "sight-readable" 
means that a regulatory agent shall be able to examine 
the record and read the information. During the 
course of an inspection, the record ma\- be read from 
the cathode ray tube, microfiche, microfilm, printout 
or other method acceptable to the Board. In the case 
of administrative proceedings before the Board. 
records must be provided in a readable paper printout 
form. 

(2) Such information shall include, but not be limited to 
the prescription requirements and records of 
dispensing as indicated in Rules .2301 and .2302 of 
this Section. 

(3) The individual pharmacist responsible for 
completeness and accuracy of the entries to the s\ stem 
must provide documentation of the fact that 
prescription information entered into the computer is 
correct. In documenting this information, the 
pharmacist shall ha\e the option of either: 

(a) providing a printout of each day's prescription 
information. That printout shall be dated and 
the individual pharmacist shall verify that the 
information indicated is correct and sign the 
printout in the same manner as a check or legal 
document (e.g. J.H. Smith, or John H. Smith). 
Such printout must be maintained three >ears 



from the date of last dispensing; or 
(b) maintaining a log book, or separate file, in 
which each individual pharmacist involved in 
such dispensing shall sign a statement each day 
attesting to the fact that the prescription 
information entered into the computer that day 
has been reviewed and is correct as shown. 
Such a book or file must be maintained at the 
pharmacy employing such a system for a period 
of three years after the date of last dispensing. 

(4) Documentation in Paragraph (3) of this Rule must be 
provided in the pharmacy within 72 hours of date of 
dispensing. 

(5) An auxiliary' recordkeeping system shall be 
established for the documentation of refills if the 
automated data processing svstem is inoperative for 
any reason. When the automated data processing 
system is restored to operation, the information 
regarding prescriptions filled, refilled or transferred 
during the inoperative period shall be entered into the 
automated data processing s>stem within the time 
equal to the number of inoperative days times three; 
for example, if the system were inoperative for five 
days then all interim data shall be entered within 15 
days of the last inoperative day. However, nothing in 
this Paragraph shall preclude the pharmacist from 
using professional Judgment for the benefit of a 
patienfs health and safety. The auxiliary record 
keeping system shall be backed up at least weekly. 

(6) A pharmacN shall make arrangements with the 
supplier of data processing services or materials to 
assure that the pharmacv' continues to have adequate 
and complete prescription and dispensing records if 
the relationship with such supplier is terminated for 
any reason. A pharmacv' shall assure continuity in the 
maintenance of records. 

(7) A current version of drug interactions software shall 
be used and policies and procedures shall be 
established to address overriding the interactions 
prompt. 

Authority- G.S. 90-85. 6(al: 90-85.26: 90-85.32: 90-W. 

.2306 RELEASE OF PHARMACY RECORDS 

The contents of written prescription orders on fHe m a 
pharmacN' or other place where prescriptions are dispensed or a 
copy of such orders ma\ be provided to the patient's parent, 
spouse, or agent for the purpose of submitting the information to 
any entity' described in G.S. 90-85.36(a)( 10). 

Authority- G.S. 90-85.6: 90-85.32: 90-85.36. 

SECTION .2500 - MISCELLANEOUS PROVISIONS 

.2502 RESPONSIBILITIES OF 

PHARMACIST-MANAGER 

(a) The pharmacist-manager shall assure that prescription 
legend drugs and controlled substances are safe and secure 



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within the pharmacy. 

(b) The pharmacist-manager employed or otherwise engaged 
to supply pharmaceutical services may have a flexible schedule 
of attendance but shall be present for at least one-half the hours 
the pharmacy is open or 32 hoixrs a week, whichever is less. 

(c) Whenever a change of ownership or change of 
pharmacist-manager occurs, the successor pharmacist-manager 
shall complete an inventory of all controlled substances in the 
pharmacy within ten days. A written record of such inventory, 
signed and dated by the successor pharmacist-manager, shall be 
maintained in the pharmacy with other controlled substances 
records for a period of three years. 

(d) The pharmacist-manager shall develop and implement a 
system of inventory record-keeping and control which will 
enable that pharmacist-manager to detect any shortage or 
discrepancy in the inventories of controlled substances at that 
pharmacy at the earliest practicable time. 

(e) The pharmacist-manager shall maintain complete authority 
and control over any and all keys to the pharmacy and shall be 
responsible for the ultimate security of the pharmacy. 

(f) These duties are in addition to the specific duties of 
pharmacist-managers at institutional pharmacies and pharmacies 
in health departments as set forth in these rules. 

(g) A person shall not serve as pharmacist-manager at more 
than one pharmacy at any one time except for limited service 
pharmacies, which will be considered by the Board on an 
individual basis upon application by the pharmacist-manager. 

(h) When a pharmacy is to be closed permanently, the 
pharmacist-manager shall inform the Board and the United 
States Drug Enforcement Administration of the closing, arrange 
for the proper disposition of the pharmaceuticals and return the 
pharmacy permit to the Board's offices within ten days of the 
closing date. The pharmacist-manager, and the pharmacy's 
owner (if the owner is other than the pharmacist-manager), shall 
transfer prescription files to another pharmacy for maintenance 
of patient therapy and shall inform the public of such transfer by 
posted notice or otherwise. Controlled substance records shall 
be retained for the period of time required b\ law. 

(i) The pharmacist-manager shall prepare a plan to safeguard 
prescription records and pharmaceuticals in the event of a 
natural disaster such as hurricane or flood. 

(j) The pharmacist-manager shall separate from the 
dispensing stock ail drug products more than six months out of 
date. 

(k) The owner representative or pharmacist-manager shall 
report to the Board of Pharmacy information that reasonably 
suggests that there is a probability that a prescription drug or 
device dispensed from a location holding a permit has caused or 
contributed to the death of a patient or customer This report 
shall be filed in writing on a form provided by the Board within 
14 days of the owner representative or pharmacist-manager's 
becoming aware of the event. The pharmacist-manager shall 
retain ah documents, labels, vials, supplies, substances and 
internal investigative reports relating to the event. All such 
items shall be made available to the Board upon request. 

(1) The Board may not disclose the identity of an owner 
representative or pharmacist-manager who makes a report under 
Paragraph (k) of this Rule, except in connection with G.S. 



90-85.36. No report made under Paragraph (k) of this Rule shall 
be discoverable or admissible into evidence or otherwise used in 
any civil action involving private parties except as provided by 
G.S. 90-85.36. 

(mj Dispensing errors which are not detected and corrected 
prior to the patient receiving the medication shall be documented 
and reported within a suitable time frame to the pharmacist- 
manager Documentation shall include pertinent chronological 
information and appropriate forms including the identity of 
individual(s) responsible. These documents shall be archived in 
a readily retrievable manner and available for inspection by the 
Board for a period of three years. These documents shall not be 
discoverable or admissible into evidence or otherwise used in 
any civil action involving private parties except as provided by 
G.S. 90-85.36. 



(m)(n] In any Board proceeding, the Board shall consider 
compliance with Paragraphs (k) and (mj of this Rule as a 
mitigating factor and noncompliance with Paragraphs (k) and 
(m) of this Rule as an aggravating factor. 

Authority G.S. 90-85.6: 90-85.21: 90-85.25. 

.2506 PHARMACIST WORK CONDITIONS 

A permit holder shall not require a pharmacist to work longer 
than 12 continuous hours per work day. A pharmacist working 
longer than six continuous hours per work day shall be allowed 
during that time period to take a 30 minute meal break and one 
additional 15 minute break. 

Authority G.S. 90-85.6: 90-85.21: 90-85.32. 

SECTION .2600 - DEVICES 

.2604 RECORDS 

(a) All orders and records for devices and medical equipment 
shall conform in all pertinent respects with Board Rules .2301 
through .2305 of this Chapt e r. Chapter and shall be maintained 
at the dispensing site. In addition to the requirements of those 
rules, the serial numbers for all devices dispensed and all 
medical equipment delivered to outpatients shall be preserved as 
part of the records; provided, that this requirement shall not 
apply to disposable devices and medical equipment. 

(b) All prescriptions and refill orders for devices and medical 
equipment shall be maintained at the dispensing site for at least 
three years. 

(c) All device and medical equipment permit holders shall 
maintain a file copy of every item sold or rented with a serial 
number or tracking number or code in compliance with FDA 
Medical Device Tracking requirements. 

Authority G.S 90-85. 3(e). (11). (r): 90-85.6: 90-85.22. 

.2609 REHABILITATION EQUIPMENT 

(a) Rehabilitation equipment suppliers shall demonstrate to the 
Board's satisfaction a working knowledge of the services 
provided and how they relate to each patient's goals as 
prescribed by the physician. 

(b) Rehabilitation equipment suppliers shall: 



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PROPOSED RULES 



(1) Actively solicit information from the physician, 
physical therapist, occupational therapist, registered 
nurse and other medical or educational personnel, as 
to the results of their assessment and evaluation of the 
patient's physical, functional and associated needs as 
well as the specific goals to be met by the enabling 
technology; 

(2) In close consultation with the referring health 
professional(s), patient, patient's family and other 
primary care providers, delineate the appropriate 
choices of commercially available and custom 
fabricated equipment to meet the specified needs of 
the patient: 

(3) Participate in the measurement of the patient, utilizing 
appropriate instruments and techniques to assure the 
fit and function of the selected equipment: 

(4) Deliver, fit and adjust the prescribed equipment: 

(5) Instruct the patient and family in the safe and proper 
use and care of the equipment provided: 

(6) Provide service and support for the equipment 
delivered through knowledgeable, skilled and highh- 
trained service personnel and w ithin 72 hours, provide 
a response to patient requests for repair service on 
equipment supplied: however, such service and 
support need not be provided unless the patient's 
account is current: 

(7) Provide a specific, written statement of warranty on 
the equipment provided, including commercial 
warranties and those for adapted or custom fabricated 
items: 

(8) Maintain liability insurance of at least one million 
dollars (SI. 000. 000) worth of coverage and when 
involved in the design, fabrication or substantial 
modification of commercially available equipment, 
also maintain product liability insurance; and 

(9) Utilize extensive, written, quality assurance 
procedures including, but not limited to: 

(A) Reviewing custom designed and fabricated 
equipment and interfacing techniques with 
commercial equipment to assure compatibility 
and safety; 

(B) Understanding the properties of the materials 
being used in custom designed and modified 
equipment to assure long term durability ; 

(C) Documenting goals and objecti\es of the 
referring medical or education personnel, as 
well as short and long term effectiveness of the 
equipment in meeting those goals and 
objectives: and 

(D) Documenting complaints and problems as 
required in Rule .1608(a)(12) of this Chapter. 

AinhorityG.S. 90-85. 3(e). (11). (r): 90-85.6: 90-85.22. 

.2611 MEDICAL EQUIPMENT 

(a) Medical equipment suppliers shall demonstrate to the 
Board's satisfaction a working knowledge of the services 
pro\ ided and how the\ relate to each patient's goals. 



(b) Medical equipment suppliers shall: 

( 1 ) Document where appropriate, information from the 
phvsician or other medical personnel as to the 
patient's specific needs to be met by the equipment 
delivered as well as the effectiveness of the equipment 
in meeting those needs: 

(2) In consultation with the referring health 
professional(s), patient, patient's family and other 
primary care providers, delineate the appropriate 
choices of commercially available equipment to meet 
the specified needs of the patient: 

(3 ) Participate in the measurement of the patient, utilizing 
appropriate instruments and techniques to assure the 
fit and function of the selected equipment: 

(4) Deliver, fit and adjust the prescribed equipment; 

(5) Instruct the patient or family in the safe and proper 
use and care of the equipment provided in compliance 
with Rule .2504: 

(6) Provide service and support for the equipment 
dispensed or delivered and, within 72 hours, provide 
a response to patient requests for repair service on 
equipment supplied: however, such service and 
support need not be provided unless the patient's 
account is current: 

(7) Maintain liability insurance of at least one million 
dollars (SI. 000.000) worth of coverage: 

(8) Demonstrate that each item sold or rented has been 
checked, is free of defect, and operates within the 
manufacturers' specifications: 

(9) Refrain from modify ing equipment to the extent that 
the modification might reasonably cause harm; 

(10) Maintain all electrical components so that they do not 
present a fire or shock hazard: 

(11) Ensure that all appropriate warning labels or labeling, 
including tags, are present on the equipment provided: 

( 1 2) Maintain documentation demonstrating that a fiinction 
and safety check of equipment was performed prior to 
set up; 

(13) Maintain an established protocol for cleaning and 
disinfecting equipment which addresses both aerobic 
and anaerobic pathogens including procedures to 
prevent cross-contamination; and 

(14) Clean and disinfect equipment according to 
manufacturers' specifications. 

(c) Medical equipment suppliers shall implement a 
comprehensive preventative maintenance program for rental 
equipment which includes the following: 

( 1 ) Procedures for problem reporting, tracking, recall, and 
resolution: 

(2) Performance of service as specified by the 
manufacturer and the documentation of such 
performance in the service records: and 

(3) Maintain documentation of repair and maintenance of 
equipment. The following information shall be 
documented in the repair log; 

(A) Type of equipment: 

(B) Manufacturer; 

(C) Model; 



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(D) Serial number; 

(E) Date of repair; 

(F) Specific repair made; and 

(G) Name of person or company performing the 
repair. 

(d) In addition to Section .2500 of this Chapter providers of 
parenteral and enteral nutrition services shall comply with the 
following counseling requirements: 

( 1 ) Utilize orientation checklists to review: 

(A) Instructions for use of the equipment; 

(B) Safety precautions; 

(C) Cleaning procedures; 

(D) Maintenance procedures; and 

(E) Return demonstrations on equipment delivered. 



(2) Instruct the patient about emergency and routine 
contact procedures; 

(3 ) Deliver and review with the patient written instruction 
materials to ensure that the patient receives adequate 
information to properly operate the equipment; and 

(4) A written plan of service shall be developed, 
implemented, and documented in the patient record. 
The plan of service shall include, but is not limited to, 
the assessment of the safety of the home environment, 
the caregiver or patient's ability to comply with the 
prescription, and the caregiver or patient's ability to 
operate and clean the equipment as instructed. 

Authority G.S. 90-85. 3(e). (U).(r): 90-85.6: 90-85.22. 



, 



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425 



I 



TEMPORAR Y RULES 



The Codifier of Rules has entered the following temporary rule(s) in the North Carolina Administrative Code. Pursuant to G.S. 
150B-21. 1(e). publication of a temporary rule in the North Carolina Register semes as a notice of rule-making proceedings 

unless this notice has been previously published by the agency. 



TITLE ISA - DEPARTMENT OF ENVIRONMENT 
AND NATURAL RESOURCES 

Rule-making Agency: DENR - Environmental Management 
Commission 

Rule Citation: ISA NCAC 2H .0226 

Effective Date: August 21. 1998 

Findings Reviewed and approved by: Beecher R. Gray' 

Authority for the rule-making: G.S. 143-215. 3(a)(1): 1997 
N.C. Sess. Laws ch. 458: 143-215.1: 143-21 5. WC. 

Reason for Proposed Action: With the enactment of HB 515. 
the moratorium that was created will serve as a basis for future 
requirements. HB 515 provides for an exception to the 
moratorium allowing the permitting of innovative animal waste 
systems that do not employ anaerobic lagoons. The intent of this 
exception, along with the proposed temporary rule. M'as to allow 
the development of innovative technologies as an alternative to 
the conventional anaerobic lagoons that are now employed. 
Even though the expiration of the moratorium is before this rule 
will become permanent, a permanent rule may be required. The 
General .Assembly is currently considering and may require an 
extension of the moratorium. The proposed rule would only be 
effective as long as Part 1. ofHB 515 is in effect. Also, this rule 
may serve as the foundation for future systems if conventional 
anaerobic lagoons are restricted in future legislation. 

Comment Procedures: Comments, statements, data, and other 
information may be submitted in writing within 60 days (until 
October 13. 1998) after the date of publication of this issue in 
the NC Register Copies of the proposed rule and information 
package may be obtained by contacting the Non-Discharge 
Permitting Unit at (919) 733-5083 (ext. 574 or 535). Written 
comments may be submitted to Kim H. Colson, Division of 
Water Quality, Water Quality Section. Non-Discharge 
Permitting Unit. PO Box 29535. Raleigh, NC 27626-0535. 

CHAPTER 2 - ENVIRONMENTAL MANAGEMENT 

SUBCHAPTER 2H - PROCEDURES FOR 
PERMITS: APPROVALS 

SECTION .0200 - WASTE NOT DISCHARGED 
TO SURFACE WATERS 

.0226 INNOVATIVE ANIMAL WASTE 
OPERATION PERMITS FOR 
SWINE OPERATIONS 



(a) In accordance with the Clean Water Responsibility And 
Environmentally Sound Policy A_ct, 1997 N.C. Sess. Laws ch. 



458. Sec. 1.1(b)(7). the Director may issue permits for a new or 
expanding swine waste operation if the operation utilizes an 
innovative animal waste management system that does not 
employ an anaerobic lagoon. For the purpose of implementing 
the Clean Water Responsibility And Environmentally Sound 
Policy Act. 1997 N.C. Sess. Laws ch. 458. an individual permit 
may be issued for a new or expanding swine farm under G.S. 
143-215. IOC if the animal waste management system meets the 
criteria as set forth in Paragraph (b) of this Rule. 

(b) An animal waste management system may be considered 
for an exception under Sec. 1.1(b)(7) of the Clean Water 
Responsibility And Environmentally Sound Policy Act. 1997 
N.C. Sess. Laws ch. 458 if 

(1) The system is installed on state or federally owned 
property, does not employ an anaerobic lagoon, and is 
a research or demonstration project; or 

(2) The system js substantially different from systems. 
other than pilot scale, currently in use in North 
Carolina on swine o perations with 250 or more swine; 
and 

(3) It appears that the system will provide the Department 
a viable alternative to the continued use of the existing 
form of anaerobic wastewater lagoons prevalent in 
North Carolina as the treatment system for swine 
waste, or it appears that the system will substantially 
advance the Department's knowledge with regard to 
significant improvements that can be made to animal 
waste management on swine farms; and 

(4) The system does not employ an anaerobic lagoon. 

(c) The following definitions apply to this Section: 

(1) "Anaerobic Lagoon" shall mean the lagoon js 
designed for the treatment of waste by converting jt 
into Carbon dioxide. Methane, other gaseous end 
products, organic acids, and cell tissue. 
"Lagoon" shall be as defined in G.S. 106-802( 1 ). 
"Anaerobic process" means a biological treatment 



12} 
0} 



process that occurs in the absence of oxygen. 

(d) Other processes, such as anoxic zones and anaerobic 
zones for nutrient removal or anaerobic digesters for the further 
treatment of residual solids, that do not include an anaerobic 
lagoon, would not prevent consideration for an exception under 
this Rule, provided the applicant can document beneficial 
aspects of the treatment with respect to ammonia volatilization, 
water quality, and odor reduction. The burden of proof shall be 
on the applicant to demonstrate this requirement. 

(e) The Director may require the use of aeration or other 
treatment in holding basins or other storage devices if there is a 
potential for anaerobic processes developing and generating 
odors on a regular basis which are detectable beyond the 
property of the operation. 



426 



NORTH CAROLINA REGISTER 



August 14, 1998 



13:4 



uujjwmww— ^Mwnuiuijmi. i>MirM.ni.f.i.^ 



TEMPORAR Y R ULES 



(f) The Director may consider whether the proposed location 
is consistent with water quahtv concerns in the watershed. 

(g) This Rule shall be in effect as long as the Clean Water 
Responsibility And Environmentally Sound Policy Act. 1997 
N.C. Sess. Laws ch. 458. Sec. 1.1 is in effect. 

History Note: Authority G.S. ] 43-2 J 5.1; 1 43-2 15. IOC; 

S.L 1997 c. 458; 

Temporary Adoption Eff. August 21, 1998. 



113-291.2; 

Eff. February 1, 1976; 

Amended Eff. July 1, 1987; July 1. 1986; July 1. 1985; July 1, 

1984; 

Temporary Amendment Eff. August 1. 1998. 



Rule-making Agency: 

Commission 



North Carolina Wildlife Resources 



Rule Citation: 15A NCAC lOB .0207 

Effective Date: August 1. 1998 

Findings Reviewed and Approved by: Beecher R. Gray 

Authority for the rule-making: G.S. 113-134; 113-2:'4; 113- 
291.1; 113-292 

Reason for Proposed Action: To set/amend the rule 
regarding possession and transportation of box trapped rabbits 
which is necessary to manage and consen'e the resource. 

Comment Procedures: The North Carolina Wildlife Resources 
Commission has the authority to adopt temporary rules 
pursuant to S.L. 1997-0403. This temporaiy rule is adopted 
following the public hearing and public comment period 
established for permanent rule adoption. A public hearing was 
held on July 2, 1998 for the permanent rule and the record of 
hearing for public comment was closed on July 15. 1998. The 
submission for permanent rule is on file with the Rules Review 
Commission. 

CHAPTER 10 -WILDLIFE RESOURCES 
AND WATER SAFETY 

SUBCHAPTER lOB - HUNTING AND TRAPPING 

SECTION .0200 -HUNTING 

.0207 RABBITS 

(a) Open Season: Saturday next preceding Thanksgiving to 
the last day of February. 

(b) Bag Limits: Daily, five: possession. 10; season. 75. 

(c) Box-traps. During the hunting season specified in 
Paragraph (a) of this Rule and subject to the bag. possession and 
season limits set forth in Paragraph (b) of this Rule, rabbits may 
be taken with box-traps. A valid hunting license shall serve as 
a transportation permit for live rabbits taken pursuant to this 
Rule. 

History Note: Authority G.S 113-134; 113-274; 113-291.1; 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



427 



RULES REVIEW COMMISSION 



1 his Section contains the agenda for the next meeting of the Rules Review Commission on Thursday. Ausust 20. 1998, 10:00 
a.m. . at 1307 GlemivodAve.. Assembly Room, Raleigh, NC. Anyone wishing to submit written comment on any rule before 
the Commission should submit those comments to the RRC staff, the agency, and the individual Commissioners by Monday. 
August 17, 1998, gl 3:00 p.m. Specific instructions and addresses may be obtained from the Rules Review Commission at 
919- 733-2 721. .Anyone wishing to address the Commission should notify the RRC staff and the agency at least 24 hours prior 
to the meeting. 



RULES REVIEW COMMISSION MEMBERS 



Appointed by Senate 

Teresa L. Smallwood, Vice Chairman 

Jim Funderburke 

Vemice B. Howard 

Philip O. Redwine 

David Twiddy 



Appointed by House 

Paul Powell, Chairman 

Anita White, 2"'' Vice Chairman 

Mark Garside 

Steve Rader 

George Robinson 



RULES REVIEW COMMISSION MEETING DATES 



July 23, 1998 
August 20, 1998 
September 17, 1998 



October 15, 1998 
November 19, 1998 



MEETING DATE: AUGUST 20, 1998 
LOG OF FILINGS 



RULES SUBMITTED: JUNE 20, 1998 THROUGH JULY 20, 1998 
AGENCY/DIVISION RULE NAME RULE CITATION 



ACTION 



DHHS/COMMISSION FOR MH/DD/SAS 

Definitions 



10NCAC45H.0201 Amend 



JUSTICE/NC ALARM SYSTEMS LICENSING BOARD 






Statement of Purpose 


12NCAC 11 .0501 


Adopt 


Definitions 


12NCAC 11 .0502 


Adopt 


Required CLE Hours 


12NCAC 11 .0503 


Adopt 


Accreditation Standards 


12NCAC 11 .0504 


Adopt 


Non-Resident Licensee 


12NCAC 11 .0505 


Adopt 


Recording and Reporting CLE Credits 


12NCAC 11 .0506 


Adopt 


Non-Compliance 


12NCAC 11 .0507 


Adopt 


EDUCATION, STATE BOARD OF 






Hearings 


16NCAC6C.0502 


Amend 


Early Admission to Kingergarten 


16NCAC6E.0105 


Adopt 


Annual Performance Standards 


16NCAC6G.0305 


Amend 


Annual Performance Standards 


16NCAC6G .0310 


Adopt 


Liability Insurance 


16NCAC6G.0501 


Adopt 


TRANSPORTATION, DEPARTMENT OF/DIVISION OF MOTOR VEHICLES 






Original Application 


19NCAC3I .0202 


Amend 


Reneal Applications 


19NCAC3I.0203 


Amend 


Requirements 


19NCAC31.0501 


Amend 


Original Application 


19NCAC3I.0502 


Amend 



42H 



NORTH CAROLINA REGISTER 



August 14, 1998 



13:4 



jMimtimVUWrnUU JLIJHI JUfcWJTirTraT 



RULES REVIEW COMMISSION 



Renewal Application 

STATE BOARDS/DENTAL EXAMINERS, BOARD OF 

Definitions 

STATE BOARDS/REAL ESTATE COMMISSION, BOARD OF 

Proof of Licensure 



I9NCAC31.0503 Amend 



21 NCAC 16V.0102 Amend 



21 NCAC58A.0101 Amend 



RULES REVIEW COMMISSION 

July 23, 1998 
MINUTES 

The Rules Review Commission met on July 23, 1998, in the Assembly Room of the Methodist Building, 1307 Glenwood 
Avenue, Raleigh, North Carolina. Commissioners in attendance were Chairman Paul Powell, Teresa L. Smallwood, Vemice B. 
Howard, George S. Robinson, Jim R. Funderburk, Anita A. White, and Mark P. Garside. 

Staff members present were: Joseph J. DeLuca, Staff Director; Bobby Bryan, Rules Review Specialist; Glenda B. Gruber, 
Administrative Assistant; and Sandy Webster. 



The following people attended: 

Valerie Chaffin 
Charlotte Hall 
Portia Rochelle 
Shamese Ransome 
Patricia Purser 
David Brown 
Dedra Alston 
Ed Norman 



Hunton & Williams 

DHHS/MH/DD/SAS 

DHHS/DMA 

DHHS/DSS 

DHHS/DSB 

DENR 

DENR 

DENR 



APPROVAL OF MINUTES 

The meeting was called to order at 10:05 a.m. with Chairman Powell presiding. He asked for any discussion, comments, or 
corrections concerning the minutes of the June 18, 1998 meeting. There being none, the minutes were approved. 

FOLLOW-UP MATTERS 

10 NCAC 14G .0102 - DHHS/Commission for MH/DD/SAS: The rewritten rule submitted by the agency was approved by the 
Commission. 

10 NCAC 41 A .0007 - DHHS/Social Services Commission: The rewritten rule submitted by the agency was approved by the 
Commission. 

15A NCAC lOG .0404 - DENR/Wildlife Resources Commission: The rewritten rule submitted by the agency was approved by 
the Commission. 

LOG OF FILINGS 

Chairman Powell presided over the review of the log and all rules were approved with the following exceptions: 

15A NCAC 7H .0310 - DENR/Coastal Resources Commission: This rule was withdrawn by the agency. 

1 5 A NCAC 1 8 A .3 1 1 , .3 1 02, .3 1 05, .3 1 08. and .3 1 09 - DENR/Commission for Health Services: The Commission objected to 
.3101 due to ambiguity and lack of necessity. Because there is no authority for setting occupational standards for workers and 
supervisors, there is no need for the definitions in (1) and (2). It is also not clear what standards the Department will use in 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



429 



RULES REVIEW COMMISSION 



approving the one day courses and video instructions. In the last sentence in (7), it is not clear if a visual inspection must include 
one of the listed activities. The Commission objected to .3 1 02 due to lack of statutory' authority. The last sentence in this rule is 
not consistent with G.S. 130A-131.7(12). As long as the lowest blood test shows a blood lead concentration of 15 - 19 
micrograms per deciliter, it is irrelevant how high the others are. The Commission objected to .3 105 due to ambiguity. In (b)(3), 
it is not clear what is meant by "properly" installed, established, and maintained. The Commission objected to .3108 due to lack 
of statutory authority and ambiguity. In (a), it is not clear what form and manner is prescribed for applications for certificates of 
compliance. In (c)( 1 ), there is no authority for the Commission to set occupational requirements for workers and supervisors 
performing work to comply with the maintenance standard. In (c)(3), it is not clear what manner has been prescribed by the 
owner for the written summary. In (c)(4), it is not clear what standards the Department will use in approving laboratories or 
methods. In (e), it is not clear what manner is prescribed by the Department. The Commission objected to .3 109 due to 
ambiguity and lack of necessity. In (e), it is not clear what method is approved by the Department. As written, the paragraph is 
meaningless since the Department sends the notice. Commissioner Rader voted not to approve the rules because they exceed 
their statutory authority in that they may arguabK require demolition of a structure. 

COMMISSION PROCEDURES AND OTHER MATTERS 

Mr. DeLuca reported on his trip to Salt Lake City for the NASS/ACR (National Association of Secretaries of 
State/Administrative Codes and Registers). The next meeting will be on August 20, 1998. 



' 



The meeting adjourned at 10:55 a.m. 

Respectfully submitted, 
Sandy Webster 



I 



430 NORTH CAROLINA REGISTER August 14, 1998 13:4 



mmmiiMu m vw\^iK\M':i ' r , r , imw\t,f 



CONTESTED CASE DECISIONS 



1 his Section contains the full text of some of the more significant Administrative Law Judge decisions along with an index 
to all recent contested cases decisions which are filed under North Carolina's Administrative Procedure Act. Copies of the 
decisions listed in the index and not published are available upon request for a minimal charge by contacting the Office of 
Administrative Hearings. (919) 733-2698. 



OFFICE OF ADMINISTRATIVE HEARINGS 

Chief Administrative Law Judge 

JULIAN MANN, III 

Senior Administrative Law Judge 

FRED G. MORRISON JR. 

ADMINISTRATIVE LAW JUDGES 



Brenda B. Becton 
Sammie Chess Jr. 
Beecher R. Gray 
Melissa Owens 



Meg Scott Phipps 

Robert Roosevelt Reilly Jr. 

Dolores O. Smith 



AGENCY 

.4LCOHOLIC BEVER.\GE CONTROL COMMISSION 

Alcoholic Beverage Control Commission \ K.enneth Jerome 
Alcoholic Beverage Control Commission v Jesse Jacob Joyner. Jr 
Alcoholic Beverage Control Commission v Axis Entertainment 
Sokha Huor Ramadneh v Alcoholic Beverage Control Commission 
Alcoholic Beverage Control Commission v Delores Williams Alnaqib 
Alcoholic Beverage Control Commission v Axis Entenainment 
Tanis Jackson v Alcoholic Beverage Control Commission 

CRIME CONTROL AND PUBLIC SAFETY 

Marcella Skaggs \ Crime Victims Compensation Commission 
Talmadge E. McHenr> \ Crime Victims Compensation Commission 
Kenneth T L\11e v Crime Victims Compensation Commission 
Mia Thompson-Clark v Crime Victims Compensation Commission 

ENMRONMENT AND NATURAL RESOlTiCES 

Teresa Heflin \ Department of Environment and Natural Resources 
Ronald Prater \ Depanment of Environment and Natural Resources 
James F Smith v Department of Environment and Natural Resources 
Hickory Alliance v Department of Environment and Natural Resources 
and 

Godfrey Lumber Compan\. Inc 
John M. Silvia v. Department of Environment and Natural Resources 
Godfrey Lumber Company. Inc \ Dept. /Environment & Natural Resources 
and 

Hickorv Alliance 
Gregor, B Jackson, Brenda R Jackson \. Greene Ct\ Hlth Dept . ENR 
Robert G GofT. Sr v Department of Environment and Natural Resources 
Scotland Water. Cedar Circle v Environment and Natural Resources 
Robert G. Goff. Sr v Department of Environment and Natural Resources 

Division of Environmental Management 

Sa\e Our Rivers. Inc . et al v Town of Highlands, EHNR, Env. Mgmt., 
William W Cobey. Jr . Secretan, 

Division of Marine Fisheries 

Lady LaShanda Melvin Bryant v EHNR. Division of Marine Fisheries 

HEALTH AND HUMAN SERVICES 

Stanley C Ochulo v OfT./Administrative Hearings. Mr R Marcus Lodge 
Oliver C- Johnson. Hazel T, Johnson v. Health and Human Services 



CASE 




DATE OF 


PUBLISHED DECISION 


NUMBER 


ALJ 


DECISION 


REGISTER CITATION 


97 ABC 1205 


Phipps 


07/23/98 




97 ABC 1438 


Phipps 


06/19/98 




98 ABC 0357*' 


Reillv 


07/02/98 




98 ABC 0382 


Smith 


06/30/98 


13:03 NCR 350 


98 ABC 0392 


Chess 


07/30/98 




98 ABC 0401*' 


Reillv 


07/02/98 




98 ABC 0768 


Smith 


07/13/98 




98 CPS 0065 


Owens 


06/05/98 




98CPS0116 


Gra\ 


06/24/98 




98 CPS 01 76 


Reillv 


07/06/98 




98 CPS 0349 


Chess 


05/14/98 




97 EHR 0409 


Morrison 


07/29/98 




97EHR0451 


Reilh 


07/02/98 




97 EHR 1365 


Chess 


07/17/98 




97 EHR 1607 


Reilly 


07/17/98 




97 EHR 1646 


Chess 


06/03/98 




97 EHR 1676 


ReilK 


07/17/98 




98 EHR 0042 


Reilh 


07/02/98 




98 EHR 0072*- 


Grav 


06/25/98 




98 EHR 0236 


Smith 


06/09/98 




98 EHR 0448*= 


Gray 


06/25/98 




91 EHR 0377 


Gra> 


07/30/98 




97 EHR 1459 


Gray 


07/20/98 




98DHR0021 


Reillv 


06/24/98 




98 DHR 0090 


Grav 


07/08/98 





13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



431 



CONTESTED CASE DECISIONS 



AGENCY 

Louise Streater v Health and Human Sen ices 

Richard E Laurence, Rebecca A Laurence \ Health and Human Senices 

CaroKn L Freeman \ Department of Human Resources 

Chnstopher Germano. Lee Germane v Department of Health 

Division of Facility Senices 

Pearlie \V Lauson \ DHHS. Facilit\ Svcs . Health Care Personnel Reg. 
Annie K Morgan v Health & Human Services . Facilit> Senices 
MooresMlle Hospital Mgmt Associates. Inc d/b/a Lake Norman Regional 

Medical Center \ DHR. Facilir. Senices. Certificate of Need Section 
and 

Autumn Corporation and McKinle\ V Jume\ 
Constellation Health Sen ices. Inc and Constellation Senior Senices. 

Inc V DHR. FacilitN Sen ices. Group Care Licensure Section 
and 

Diversified Health Group. LLC and The lnno\ati\e Health Group. Inc 
Sunlite Retirement Home. Winnie Jane Johnson \ DHR. FaciliP. Sen ices 
.\nn Da\is Rest Home \ Group Care Licensure Section 
Diane Lingard \ DHR. Facilit\ S\cs. Health Care Personnel Reg 
KimberU .Annene Smith Hull v DHHS. Division of Facilm Senices 
Deborah .Ann Holt \ DHHS. Division of Facilitv Senices 
.■\nnie K Morgan \ Health & Human Senices . Facilm Sen ices 
Johnnie E Williams \ DHHS. Division of Facilit\ Senices 

Division of Medical Assistance 

Charlotte-Mecklenburg Hospital .Authontv. d/b/a Carolinas Medical Ctr. 
and Ham .Mahannah. M D \ DHHS. Division of Medical .Assistance 



CASE 




DATE OF 


MMBER 


AU 


DECISION 


98 DHR 0196 


Grav 


06/03/98 


98 DHR 0209 


Phipps 


07/15/98 


98 DHR 0721 


Grav 


08/05/98 


98 DHR 0780 


Ouens 


07/28/98 


97 DHR 1034 


Becton 


07/30/98 


97 DHR I046»' 


Phipps 


07/23/98 


97 DHR 1209 


ReilK 


06/23/98 



PIBLISHED DECISION 
REGISTER CITATION 



97 DHR 1529 



Grav 



06/24/98 



98 DHR 0124 


Phipps 


06/11/98 


98 DHR 0197 


Phipps 


06/23/98 


98 DHR 02 14 


Becton 


06/22/98 


98 DHR 0239 


Phipps 


06/23/98 


98 DHR 0348 


Phipps 


06/22/98 


98 DHR 0496*' 


Phipps 


07/23/98 


98 DHR 0639 


ReilK 


07/02/98 


97 DHR 0621 


Smith 


07/08/98 



Division of Social Services 

William & Cn.stal Steakles \ DHHS. Dnision of Social Senices 

Ran .Abdus-Salaam v Depanment of Human Resources. DSS-DCA 

Child Support Enforcement Section 
JefFen LeeGra\es\ Depanment of Human Resources 
Donald L Carr. Jr \ Department of Human Resources 
Man in Diggs \ Department of Human Resources 
Dennis Lee McNeill \ Department of Human Resources 
BvTon O .Ashbv II v Depanment of Human Resources 
Michael .A Wilder \ Depanment of Human Resources 
Bills .Anthons Jr \ Depanment of Human Resources 
.•\lton D Bagle\ \ Depanment of Human Resources 
Bemel B Berrs Jr \ Depanment of Human Resources 
.Anthonx Montgomer. \ Depanment of Human Resources 
Tern. Letterman \ Department of Human Resources 
.\nnene Chipman \ Department of Human Resources 
Paul J Moble\.Jr\ Department of Human Resources 
Robert .A Shererv Department of Human Resources 
Rodger Hazen II \ Depanment of Human Resources 
Wade .A Burgess \ Department of Human Resources 
Robert L Robinson v Department of Human Resources 
Jamie .A Hunts Depanment of Health & Human Senices 
Renardo Jenkins v Depanment of Human Resources 
.Anthons Love \ Depanment of Human Resources 
Ste\en Kent Gold \ Depanment of Human Resources 
Lerov J Poole \ Department of Human Resources 
Hoval .A McLean \ Department of Health & Human Senices 
Michael Bernard Hill v Department of Health & Human Senices 
Charlie RallitTJr \ Depanment of Health &. Human Senices 
John B Hall \ Department of Human Resources 
Tabatha D Pate \ Department of Human Resources 
.Amanda F Blount \ Department of Human Resources 
Charlie Gras Hunt Jr \ Department of Human Resources 
Robert L Williams \ Department of Human Resources 
Teresa L Gallouav \ Department of Health & Human Senices 
Vernon Reginald Pinknev \ Depanment of Health & Human Senices 
Elijah G Deans \ Depanment of Health & Human Senices 
Vickie E Lane \ Michael L Adams. Depanment of Human Resources 
Janice Scott Padgett i Fisher) v Depanment of Human Resources 
Barbara Fanta-Blandine \ Depanment of Human Resources 
Sharon Bnm \ [)epanment of Health & Human Senices 
Terita M Sharpe \ Department of Human Resources 
Ruth McFadden \ Depanment of Human Resources 



98 DHR 0076 


Grav 


07'20/98 


98 DHR 0771 


Ov\ens 


07/30/98 


98CR.A0I37 


Becton 


06/23/98 


98 CR-A 0545 


Reillv 


06/08/98 


98CRA0588 


Reillv 


06/24/98 


96CSE 1305 


Grav 


06/22/98 


96CSE 1435 


Mann 


07/15/98 


97CSE 1301 


Chess 


07/17/98 


97CSE 1393 


Reillv 


06/24/98 


97CSE 1424 


Chess 


06/02/98 


97CSE 1435 


Smith 


06/12/98 


97CSE 1442 


Phipps 


06/17/98 


97CSE 1492 


Smith 


06/22/98 


97 CSE 1 545 


Phipps 


07/23/98 


97CSE1568 


Phipps 


06/17/98 


97 CSE 1605 


Mann 


07'15/98 


97 CSE 1666 


Chess 


07/17/98 


98 CSE 0071 


Morrison 


06/12/98 


98 CSE 0130 


ReilK 


07'15/98 


98 CSE 0307 


Morrison 


07/06/98 


98 CSE 03 10 


Smith 


06/23/98 


98 CSE 0312 


Phipps 


06/23/98 


98 CSE 0333 


Momson 


07/01/98 


98 CSE 0375 


Reillv 


07/02/98 


98 CSE 0420 


Smith 


07/29/98 


98 CSE 0421 


Becton 


07/15/98 


98 CSE 0449 


Mann 


07/15/98 


98 CSE 0506 


Chess 


07/20/98 


98 CSE 0556 


Becton 


06/23/98 


98 CSE 0560 


Chess 


07/29/98 


98 CSE 0607 


Smith 


06'22/98 


98 CSE 0682 


Smith 


06,'22/98 


98 CSE 0769 


Becton 


07/30/98 


98 CSE 0833 


Ouens 


07/29/98 


98 CSE 0867 


Phipps 


07/20/98 


96 DCS 2105 


Grav 


07/08/98 


97 DCS 1219 


Smith 


07/29/98 


97 DCS 1486 


Momson 


06/22/98 


97 DCS 1574 


Grav 


08/04/98 


98 DCS 0468 


Momson 


06/09/98 


98 DCS 0675 


Reillv 


07/15/98 



432 



NORTH CAROLINA REGISTER 



August 14, 1998 



13:4 



CONTESTED CASE DECISIONS 



TrnirrrriifT'Tmrna 



AGENCY 



CASE 
NLtMBER 



ALJ 



DATE OF 
DECISION 



PIBLISHED DECISION 
REGISTER CITATION 



Division of Women 's and Children 's Health 

Joseph A Nawas v, DHHS, Women's/Children's Health, Nutrition Svcs 

JUSTICE 



98 DHR 0637 



Phipps 



07/02/98 



Alarm Systems Licensing Board 

Claude David Huggins v Alarm Systems Licensing Board 

Auctioneer Licensing Board 

Wiley R Tyndall v Auctioneer Licensing Board 

Education and Training Standards Division 

Thomas Dwayne Brown v Sheriffs' Education & Training Standards Comm 
Odis Fitzgerald Darden v Sheriffs' Education & Training Standards Comm 
Hoyle Kenneth Wise, Jr v. Sheriffs' Education & Training Standards Comm 
Hearl Oxendine v. Criminal Justice Education & Training Stds Comm 
James Farrell Roberts v Criminal Justice Education & Training Stds Comm 
Phillip Keith McPherson v ShentTs' Education & Training Standards Comm 
Dary I LaMar Bryant \ Sheriffs' Education & Training Standards Comm 
William Scott Key v Sheriffs' Education & Training Standards Comm 
Johnny Wayne Wills v Criminal Justice Education & Training Stds Comm 
Paul Harvey Taylor v, DOJ, Criminal Justice Ed & Training Stds Comm 

BOARD OF MEDICAL EXAMINERS 

Joe D Crauford, M D, v Medical Bd ofNC Bd of Medical Examiners 

PI BLIC INSTRUCTION 

Nicholas Eirschele. By and Throught His Parents, Charles & Kathleen 
Eirschele v. Craven Countv Board of Education 



98 DOJ 0871 


Morrison 


07/09/98 


97 DOJ 1236 


Phipps 


07/24/98 


97 DOJ 1319 


Phipps 


07/29/98 


97 DOJ 1 698 


Reilly 


06/12/98 


98 DOJ 0022 


Smith 


07/14/98 


98 DOJ 0121 


Smith 


06/22/98 


98 DOJ 0147 


Smith 


07/16/98 


98 DOJ 0388 


Reilly 


07/24/98 


98 DOJ 0430 


Grav 


07/21/98 


98 DOJ 0432 


Becton 


06/08/98 


98 DOJ 0574 


Chess 


07/30/98 


98 DOJ 0841 


Phipps 


07/10/98 


98BME0870 


Owens 


07/30/98 


97EDC 1234 


Phipps 


07/16/98 



STATE PERSONNEL 

Department of Correction 

Terry f Rees v Department of Correction 

Leon Owens v Department of Correction 

Teny T Rees v Department of Correction 

Jayne D Bledsoe v Correction, Div of Adult Probation & Parole 

Carl W Craven. II v Pender Correctional Institution 

Tommy L Hancock v. Department of Correction 

Crime Control and Public Safety 

Roger D Davis v Crime Control & Public Safety. St Hwy Patrol 
Albert R Little v Crime Control & Public Safety. Info Sys Specialists 

Employment Security Commission 

Jane B Bolin and Arlene G Sellers \ Employment Securit> Commission 
Jane B Bolm and Arlene G Sellers \ Employment Security Commission 

Environment and Natural Resources 

Charles Anthony Bruce v ENR. Di\ ision of Parks and Recreation 

Health and Human Services 

Angela M Miles v Cumberland County Department of Social Services 
Chanty Swick v Cumberland County Department of Social Ser\ ices 
Ruth Holroyd v Montgomer> Cty DSS. Children's Services 
James W Crews v DHHS. Murdoch Center 
Patricia R Quick v DHHS. Dorothea Dix Hospital 
Angela M Miles v Cumberland County Department of Social Services 
Delores Laveme Rich v Health & Human Sen ices. Dorothea Dix Hosp 
Anthony M Ruiz v Department of Health & Human Svcs. Youth Svcs 
Rudolph Waters \ DHHS. Youth Services. Dobbs School 
Jeffrey L Williams v Dorothea Dix Hospital 

Barbara Jean Paquette v Durham County (respondeat superior for the 
Durham County Public Library) 

Secretary of State 

Jonathan M Demers v Department of Secretar> of State 

Department of Transportation 

Larry W Da\is v Department of Transportation 



97 0SP I671»' 


Smith 


98OSP0050 


Becton 


98OSP0119*^ 


Smith 


98 OSP 0543 


Owens 


98 OSP 0633 


Smith 


98 OSP 0881 


Owens 


97 OSP 06 17 


Chess 


97 OSP 1157 


Morrison 


97 OSP 1122"' 


Chess 


97 OSP 1134*' 


Chess 


98 OSP 0240 


Reilly 


97 OSP 0613*' 


Grav 


97 OSP 0775 


Gray 


97 OSP 1586 


Smith 


98 OSP 0060 


Gray 


98 OSP 0061 


Becton 


98 OSP 0084*' 


Grav 


98 OSP 0120 


Grav 


98 OSP 0454 


Grav 


98 OSP 0474 


Morrison 


98 OSP 0595 


Becton 


98 OSP 0765 


Mortison 



97OSP10IS 



98 OSP 0241 



Becton 



Grav 



06/30/98 
07/10/98 
06/30/98 
07/29/98 
06/25/98 
08/04/98 



05/27/98 
07/22/98 



06/02/98 
06/02/98 



06/08/98 



07/10/98 
07/10/98 
05/27/98 
07/20/98 
07/16/98 
07/10/98 
07/08/98 
06/04/98 
07/30/98 
07/22/98 
08/05/98 



07/07/98 



07/08/98 



13 02 NCR 257 



13 03 NCR 343 



Consolidated Cases. 



13:4 



NORTH CAROLINA REGISTER 



August 14, 1998 



433 



COS TESTED CASE DECISIONS 



L'nhersity ofSonh Carolina 

Douglas Lo\e. Jr \ UNC Hospitals 

Deborah J Fenner \ NC Central Universm 

JosceM Smith \ Nonh Carolina Central Universm 

Eduin Suain \ Universm of Nonh Carolina at Chapel Hill 

Leo Watford. Roosevelt Pams. Claiborne Baker, et al % Universm of 

Nonh Carolina at Chapel Hill 
Jonathan L Fann v North Carolina State Universm Ph\sical Plant 

STATE TREASl RER 

Hugh A Wells \ Consolidated Judicial Retirement Svstem of NC: 
Bd of Trustees Teachers and Slate Emplosees' Retirement Svstem 



97 OS? 0662 


Reillv 


97 OSP 0902 


Chess 


97 0SP 1297 


Smith 


97 OSP 1694 


Momson 


98 OSP 0254 


Chess 


98 OSP 0465 


Becton 


98DST0316 


Morrison 



06/08/98 

05/29/98 
06/25/98 
07/31/98 
07/17/98 

07/17/98 



06/05/98 



13:01 NCR 166 



TRANSPORTATION 

DaMd Warren De« et al 



Motor Vehicles. Alexander killens Comm 



95 DOT 1144 



GraN 



06/04/98 



I NI\ ERSIT'i OF NORTH CAROLINA 

Ladonna P James \ L'NC Hospitals 



98 UNC 0591 



Becton 



07/20/98 



434 



\ORTH CAROLIXA REGISTER 



August 14. 1998 



13:4 



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